Xeridiem Mediem Medical Devices Inc: A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.

Agency Publication Date: February 26, 2016

Affected Products

Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00548460 (XMD P/N 70-0050-D14) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00548460 (XMD P/N 70-0050-D14) Lot Number: 929614

Lot Numbers:

Number

Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00548330 (XMD P/N 70-0050-014) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00548330 (XMD P/N 70-0050-014) Lot Numbers: 928905 930835

Lot Numbers:

Numbers

Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00548220 (XMD P/N 70-0050-112) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00548220 (XMD P/N 70-0050-112) Lot Numbers: 911102 915402 915902 919001 920602 928902 930823

Lot Numbers:

Numbers

Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00548340 (XMD P/N 70-0050-114) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00548340 (XMD P/N 70-0050-114) Lot Numbers: 911105 915905 920605 928906 930863

Lot Numbers:

Numbers

Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00548500 (XMD P/N 70-0050-116) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00548500 (XMD P/N 70-0050-116) Lot Numbers: 928913

Lot Numbers:

Numbers

Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00548660 (XMD P/N 70-0050-118) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00548660 (XMD P/N 70-0050-118) Lot Numbers: 923307 929719

Lot Numbers:

Numbers

Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00548820 (XMD P/N 70-0050-120) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00548820 (XMD P/N 70-0050-120) Lot Numbers: 929724

Lot Numbers:

Numbers

Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00549310 (XMD P/N 70-0050-122) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00549310 (XMD P/N 70-0050-122) Lot Numbers: 930138

Lot Numbers:

Numbers

Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00548230 (XMD P/N 70-0050-212) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00548230 (XMD P/N 70-0050-212) Lot Numbers: 911103 915403 915903 919002 920603 928903 930822

Lot Numbers:

Numbers

Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00548350 (XMD P/N 70-0050-214) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00548350 (XMD P/N 70-0050-214) Lot Numbers: 911106 915906 919003 920606 928907 930837

Lot Numbers:

Numbers

Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00548510 (XMD P/N 70-0050-216) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00548510 (XMD P/N 70-0050-216) Lot Numbers: 928914

Lot Numbers:

Numbers

Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00548670 (XMD P/N 70-0050-218) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00548670 (XMD P/N 70-0050-218) Lot Numbers: 928918 929708

Lot Numbers:

Numbers

Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00548830 (XMD P/N 70-0050-220) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00548830 (XMD P/N 70-0050-220) Lot Number: 929725

Lot Numbers:

Number

Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00549320 (XMD P/N 70-0050-222) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00549320 (XMD P/N 70-0050-222) Lot Number: 930139

Lot Numbers:

Number

Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00548240 (XMD P/N 70-0050-312) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00548240 (XMD P/N 70-0050-312) Lot Number: 911104 915404 915904 920604 928904 930821

Lot Numbers:

Number

Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00548360 (XMD P/N 70-0050-314) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00548360 (XMD P/N 70-0050-314) Lot Number: 911107 915907 919004 920607 928908 930838

Lot Numbers:

Number

Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00548520 (XMD P/N 70-0050-316) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00548520 (XMD P/N 70-0050-316) Lot Number: 911110 915910 920210 920610 928915 930825

Lot Numbers:

Number

Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00548680 (XMD P/N 70-0050-318) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00548680 (XMD P/N 70-0050-318) Lot Number: 928919 929709

Lot Numbers:

Number

Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00548840 (XMD P/N 70-0050-320) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00548840 (XMD P/N 70-0050-320) Lot Number: 929726

Lot Numbers:

Number

Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00549330 (XMD P/N 70-0050-322) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00549330 (XMD P/N 70-0050-322) Lot Number: 930140

Lot Numbers:

Number

Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00549470 (XMD P/N 70-0050-324) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00549470 (XMD P/N 70-0050-324) Lot Number: 930153

Lot Numbers:

Number

Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00548250 (XMD P/N 70-0050-412) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00548250 (XMD P/N 70-0050-412) Lot Number: 929601

Lot Numbers:

Number

Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00548370 (XMD P/N 70-0050-414) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00548370 (XMD P/N 70-0050-414) Lot Number: 911108 915408 915908 920608 928909 930839

Lot Numbers:

Number

Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00548530 (XMD P/N 70-0050-416) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00548530 (XMD P/N 70-0050-416) Lot Number: 911111 915911 920211 919005 920611 928916 930826

Lot Numbers:

Number

Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00548690 (XMD P/N 70-0050-418) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00548690 (XMD P/N 70-0050-418) Lot Number: 928920 929710

Lot Numbers:

Number

Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00548850 (XMD P/N 70-0050-420) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00548850 (XMD P/N 70-0050-420) Lot Number: 929727

Lot Numbers:

Number

Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00549340 (XMD P/N 70-0050-422) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00549340 (XMD P/N 70-0050-422) Lot Number: 930141

Lot Numbers:

Number

Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00549480 (XMD P/N 70-0050-424) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00549480 (XMD P/N 70-0050-424) Lot Number: 930154

Lot Numbers:

Number

Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00548260 (XMD P/N 70-0050-512) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00548260 (XMD P/N 70-0050-512) Lot Number: 929602

Lot Numbers:

Number

Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00548380 (XMD P/N 70-0050-514) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00548380 (XMD P/N 70-0050-514) Lot Number: 911109 915409 915909 920609 928910 930840

Lot Numbers:

Number

Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00548540 (XMD P/N 70-0050-516) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00548540 (XMD P/N 70-0050-516) Lot Number: 911112 915912 919006 920612 929624

Lot Numbers:

Number

Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00548700 (XMD P/N 70-0050-518) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00548700 (XMD P/N 70-0050-518) Lot Number: 928921 929711

Lot Numbers:

Number

Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00548860 (XMD P/N 70-0050-520) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00548860 (XMD P/N 70-0050-520) Lot Number: 929728

Lot Numbers:

Number

Product: EndoVive 3s Low Profile Balloon Kits Part Number: M005489350 (XMD P/N 70-0050-522) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/o

Part Number: M005489350 (XMD P/N 70-0050-522) Lot Number: 930142

Lot Numbers:

Number

Product: EndoVive 3s Low Profile Balloon Kits Part Number: M005489490 (XMD P/N 70-0050-524) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/o

Part Number: M005489490 (XMD P/N 70-0050-524) Lot Number: 930155

Lot Numbers:

Number

Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00548270 (XMD P/N 70-0050-612) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00548270 (XMD P/N 70-0050-612) Lot Number: 929603

Lot Numbers:

Number

Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00548390 (XMD P/N 70-0050-614) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00548390 (XMD P/N 70-0050-614) Lot Number: 928911

Lot Numbers:

Number

Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00548550 (XMD P/N 70-0050-616) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00548550 (XMD P/N 70-0050-616) Lot Number: 928917 929625

Lot Numbers:

Number

Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00548710 (XMD P/N 70-0050-618) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00548710 (XMD P/N 70-0050-618) Lot Number: 928922 929712

Lot Numbers:

Number

Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00548870 (XMD P/N 70-0050-620) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00548870 (XMD P/N 70-0050-620) Lot Number: 929729

Lot Numbers:

Number

Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00549360 (XMD P/N 70-0050-622) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00549360 (XMD P/N 70-0050-622) Lot Number: 930143

Lot Numbers:

Number

Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00549500 (XMD P/N 70-0050-624) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00549500 (XMD P/N 70-0050-624) Lot Number: 930156

Lot Numbers:

Number

Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00548280 (XMD P/N 70-0050-712) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00548280 (XMD P/N 70-0050-712) Lot Number: 929604

Lot Numbers:

Number

Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00548400 (XMD P/N 70-0050-714) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00548400 (XMD P/N 70-0050-714) Lot Number: 928912

Lot Numbers:

Number

Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00548560 (XMD P/N 70-0050-716) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00548560 (XMD P/N 70-0050-716) Lot Number: 929626

Lot Numbers:

Number

Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00548720 (XMD P/N 70-0050-718) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00548720 (XMD P/N 70-0050-718) Lot Number: 928923 929713

Lot Numbers:

Number

Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00548880 (XMD P/N 70-0050-720) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00548880 (XMD P/N 70-0050-720) Lot Number: 930129

Lot Numbers:

Number

Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00549370 (XMD P/N 70-0050-722) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00549370 (XMD P/N 70-0050-722) Lot Number: 930144

Lot Numbers:

Number

Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00549510 (XMD P/N 70-0050-724) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00549510 (XMD P/N 70-0050-724) Lot Number: 930827

Lot Numbers:

Number

Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00548290 (XMD P/N 70-0050-812) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00548290 (XMD P/N 70-0050-812) Lot Number: 929605

Lot Numbers:

Number

Product: EndoVive 3s Low Profile Balloon Kits Part Number: MM00548410 (XMD P/N 70-0050-814) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/o

Part Number: MM00548410 (XMD P/N 70-0050-814) Lot Number: 929609

Lot Numbers:

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Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00548570 (XMD P/N 70-0050-816) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00548570 (XMD P/N 70-0050-816) Lot Number: 929622

Lot Numbers:

Number

Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00548890 (XMD P/N 70-0050-820) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00548890 (XMD P/N 70-0050-820) Lot Number: 923308

Lot Numbers:

Number

Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00549380 (XMD P/N 70-0050-822) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00549380 (XMD P/N 70-0050-822) Lot Number: 930145

Lot Numbers:

Number

Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00549520 (XMD P/N 70-0050-824) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00549520 (XMD P/N 70-0050-824) Lot Number: 930828

Lot Numbers:

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Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00548300 (XMD P/N 70-0050-912) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00548300 (XMD P/N 70-0050-912) Lot Number: 929606

Lot Numbers:

Number

Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00548420 (XMD P/N 70-0050-914)

Part Number: M00548420 (XMD P/N 70-0050-914) Lot Number: 929610

Lot Numbers:

Number

Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00548580 (XMD P/N 70-0050-916) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00548580 (XMD P/N 70-0050-916) Lot Number: 929623

Lot Numbers:

Number

Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00548740 (XMD P/N 70-0050-918) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00548740 (XMD P/N 70-0050-918) Lot Number: 929715

Lot Numbers:

Number

Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00548900 (XMD P/N 70-0050-920) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00548900 (XMD P/N 70-0050-920) Lot Number: 930130

Lot Numbers:

Number

Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00549390 (XMD P/N 70-0050-922) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00549390 (XMD P/N 70-0050-922) Lot Number: 930146

Lot Numbers:

Number

Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00549530 (XMD P/N 70-0050-924) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00549390 (XMD P/N 70-0050-922) Lot Number: 930841

Lot Numbers:

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Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00548310 (XMD P/N 70-0050-A12) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00548310 (XMD P/N 70-0050-A12) Lot Number: 929607

Lot Numbers:

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Product: EndoVive 3s Low Profile Balloon Kits Part Number M00548430 (XMD P/N 70-0050-A14) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00548430 (XMD P/N 70-0050-A14) Lot Number: 929611

Lot Numbers:

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Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00548590 (XMD P/N 70-0050-A16) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00548590 (XMD P/N 70-0050-A16) Lot Number: 929701

Lot Numbers:

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Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00548750 (XMD P/N 70-0050-A18)

Part Number: M00548750 (XMD P/N 70-0050-A18) Lot Number: 929716

Lot Numbers:

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Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00548910 (XMD P/N 70-0050-A20) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00548910 (XMD P/N 70-0050-A20) Lot Number: 930131

Lot Numbers:

Number

Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00549400 (XMD P/N 70-0050-A22) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00549400 (XMD P/N 70-0050-A22) Lot Number: 930147

Lot Numbers:

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Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00549540 (XMD P/N 70-0050-A24) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00549540 (XMD P/N 70-0050-A24) Lot Number: 930829

Lot Numbers:

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Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00548320 (XMD P/N 70-0050-B12) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00548320 (XMD P/N 70-0050-B12) Lot Number: 929608

Lot Numbers:

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Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00548440 (XMD P/N 70-0050-B14) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00548440 (XMD P/N 70-0050-B14) Lot Number: 929612

Lot Numbers:

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Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00548600 (XMD P/N 70-0050-B16) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00548600 (XMD P/N 70-0050-B16) Lot Number: 929702

Lot Numbers:

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Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00548760 (XMD P/N 70-0050-B18) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00548760 (XMD P/N 70-0050-B18) Lot Number: 929717

Lot Numbers:

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Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00548920 (XMD P/N 70-0050-B20) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00M00548920 (XMD P/N 70-0050-B20) Lot Number: 929132

Lot Numbers:

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Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00549410 (XMD P/N 70-0050-B22) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00549410 (XMD P/N 70-0050-B22) Lot Number: 930148

Lot Numbers:

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Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00549550 (XMD P/N 70-0050-B24) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00549550 (XMD P/N 70-0050-B24) Lot Number: 930834

Lot Numbers:

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Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00548450 (XMD P/N 70-0050-C14) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00548450 (XMD P/N 70-0050-C14) Lot Number: 929613

Lot Numbers:

Number

Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00548610 (XMD P/N 70-0050-C16) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00548610 (XMD P/N 70-0050-C16) Lot Number: 929703

Lot Numbers:

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Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00548770 (XMD P/N 70-0050-C18) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00548770 (XMD P/N 70-0050-C18) Lot Number: 929718

Lot Numbers:

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Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00548930 (XMD P/N 70-0050-C20) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00548930 (XMD P/N 70-0050-C20) Lot Number: 930133

Lot Numbers:

Number

Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00549420 (XMD P/N 70-0050-C22) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00549420 (XMD P/N 70-0050-C22) Lot Number: 923309

Lot Numbers:

Number

Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00549560 (XMD P/N 70-0050-C24) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00549560 (XMD P/N 70-0050-C24) Lot Number: 930830

Lot Numbers:

Number

Part Number: M00548460 (XMD P/N 70-0050-D14) Lot Number: 929614

Lot Numbers:

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Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00548620 (XMD P/N 70-0050-D16) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00548620 (XMD P/N 70-0050-D16) Lot Number: 929704

Lot Numbers:

Number

Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00548780 (XMD P/N 70-0050-D20) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00548780 (XMD P/N 70-0050-D20) Lot Number: 929720

Lot Numbers:

Number

Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00549430 (XMD P/N 70-0050-D22) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00549430 (XMD P/N 70-0050-D22) Lot Number: 930149

Lot Numbers:

Number

Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00549570 (XMD P/N 70-0050-D24) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00549570 (XMD P/N 70-0050-D24) Lot Number: 930831

Lot Numbers:

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Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00548470 (XMD P/N 70-0050-E14) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00548470 (XMD P/N 70-0050-E14) Lot Number: 929615

Lot Numbers:

Number

Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00548630 (XMD P/N 70-0050-E16) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00548630 (XMD P/N 70-0050-E16) Lot Number: 929705

Lot Numbers:

Number

Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00548790 (XMD P/N 70-0050-E18) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00548790 (XMD P/N 70-0050-E18) Lot Number: 929721

Lot Numbers:

Number

Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00548950 (XMD P/N 70-0050-E20) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00548950 (XMD P/N 70-0050-E20) Lot Number: 930135

Lot Numbers:

Number

Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00549440 (XMD P/N 70-0050-E22) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00549440 (XMD P/N 70-0050-E22) Lot Number: 930150

Lot Numbers:

Number

Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00549580 (XMD P/N 70-0050-E24) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00549580 (XMD P/N 70-0050-E24) Lot Number: 930832

Lot Numbers:

Number

Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00548480 (XMD P/N 70-0050-F14) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00548480 (XMD P/N 70-0050-F14) Lot Number: 929616

Lot Numbers:

Number

Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00548640 (XMD P/N 70-0050-F16) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00548640 (XMD P/N 70-0050-F16) Lot Number: 929706

Lot Numbers:

Number

Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00548800 (XMD P/N 70-0050-F18) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00548800 (XMD P/N 70-0050-F18) Lot Number: 929722

Lot Numbers:

Number

Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00548960 (XMD P/N 70-0050-F20) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00548960 (XMD P/N 70-0050-F20) Lot Number: 930136

Lot Numbers:

Number

Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00549450 (XMD P/N 70-0050-F22) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00549450 (XMD P/N 70-0050-F22) Lot Number: 930151

Lot Numbers:

Number

Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00549590 (XMD P/N 70-0050-F24) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00549590 (XMD P/N 70-0050-F24) Lot Number: 930833

Lot Numbers:

Number

Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00548490 (XMD P/N 70-0050-G14) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00548490 (XMD P/N 70-0050-G14) Lot Number: 929617

Lot Numbers:

Number

Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00548650 (XMD P/N 70-0050-G16) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00548650 (XMD P/N 70-0050-G16) Lot Number: 929707

Lot Numbers:

Number

Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00548810 (XMD P/N 70-0050-G18) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00548810 (XMD P/N 70-0050-G18) Lot Number: 929723

Lot Numbers:

Number

Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00548970 (XMD P/N 70-0050-G20) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00548970 (XMD P/N 70-0050-G20) Lot Number: 930137

Lot Numbers:

Number

Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00549460 (XMD P/N 70-0050-G22) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00549460 (XMD P/N 70-0050-G22) Lot Number: 930152

Lot Numbers:

Number

Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00549600 (XMD P/N 70-0050-G24) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Part Number: M00549600 (XMD P/N 70-0050-G24) Lot Number: 923310

Lot Numbers:

Number

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 73024

Status: Resolved

Manufacturer: Xeridiem Mediem Medical Devices Inc

Manufactured In: United States

Units Affected: 105 products (36; 91; 260; 199; 39; 165; 40; 40; 243; 326; 39; 77; 40; 33; 235; 331; 191; 78; 34; 32; 37; 38; 323; 189; 77; 37; 40; 35; 39; 205; 186; 80; 40; 36; 34; 40; 36; 154; 77; 37; 35; 40; 32; 36; 115; 76; 37; 31; 43; 36; 39; 91; 126; 36; 38; 38; 40; 38; 40; 36; 37; 34; 40; 36; 40; 39; 40; 39; 40; 39; 36; 40; 37; 40; 40; 38; 39; 40; 40; 40; 126; 39; 36; 40; 40; 40; 40; 38; 40; 40; 40; 37; 37; 36; 31; 40; 39; 40; 36; 37; 39; 40; 38; 32; 162)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products

Part Number: M00548460 (XMD P/N 70-0050-D14) Lot Number: 929614

Lot Numbers:

Number

Part Number: M00548330 (XMD P/N 70-0050-014) Lot Numbers: 928905 930835

Lot Numbers:

Numbers

Part Number: M00548220 (XMD P/N 70-0050-112) Lot Numbers: 911102 915402 915902 919001 920602 928902 930823

Lot Numbers:

Numbers

Part Number: M00548340 (XMD P/N 70-0050-114) Lot Numbers: 911105 915905 920605 928906 930863

Lot Numbers:

Numbers

Part Number: M00548500 (XMD P/N 70-0050-116) Lot Numbers: 928913

Lot Numbers:

Numbers

Part Number: M00548660 (XMD P/N 70-0050-118) Lot Numbers: 923307 929719

Lot Numbers:

Numbers

Part Number: M00548820 (XMD P/N 70-0050-120) Lot Numbers: 929724

Lot Numbers:

Numbers

Part Number: M00549310 (XMD P/N 70-0050-122) Lot Numbers: 930138

Lot Numbers:

Numbers

Part Number: M00548230 (XMD P/N 70-0050-212) Lot Numbers: 911103 915403 915903 919002 920603 928903 930822

Lot Numbers:

Numbers

Part Number: M00548350 (XMD P/N 70-0050-214) Lot Numbers: 911106 915906 919003 920606 928907 930837

Lot Numbers:

Numbers

Part Number: M00548510 (XMD P/N 70-0050-216) Lot Numbers: 928914

Lot Numbers:

Numbers

Part Number: M00548670 (XMD P/N 70-0050-218) Lot Numbers: 928918 929708

Lot Numbers:

Numbers

Part Number: M00548830 (XMD P/N 70-0050-220) Lot Number: 929725

Lot Numbers:

Number

Part Number: M00549320 (XMD P/N 70-0050-222) Lot Number: 930139

Lot Numbers:

Number

Part Number: M00548240 (XMD P/N 70-0050-312) Lot Number: 911104 915404 915904 920604 928904 930821

Lot Numbers:

Number

Part Number: M00548360 (XMD P/N 70-0050-314) Lot Number: 911107 915907 919004 920607 928908 930838

Lot Numbers:

Number

Part Number: M00548520 (XMD P/N 70-0050-316) Lot Number: 911110 915910 920210 920610 928915 930825

Lot Numbers:

Number

Part Number: M00548680 (XMD P/N 70-0050-318) Lot Number: 928919 929709

Lot Numbers:

Number

Part Number: M00548840 (XMD P/N 70-0050-320) Lot Number: 929726

Lot Numbers:

Number

Part Number: M00549330 (XMD P/N 70-0050-322) Lot Number: 930140

Lot Numbers:

Number

Part Number: M00549470 (XMD P/N 70-0050-324) Lot Number: 930153

Lot Numbers:

Number

Part Number: M00548250 (XMD P/N 70-0050-412) Lot Number: 929601

Lot Numbers:

Number

Part Number: M00548370 (XMD P/N 70-0050-414) Lot Number: 911108 915408 915908 920608 928909 930839

Lot Numbers:

Number

Part Number: M00548530 (XMD P/N 70-0050-416) Lot Number: 911111 915911 920211 919005 920611 928916 930826

Lot Numbers:

Number

Part Number: M00548690 (XMD P/N 70-0050-418) Lot Number: 928920 929710

Lot Numbers:

Number

Part Number: M00548850 (XMD P/N 70-0050-420) Lot Number: 929727

Lot Numbers:

Number

Part Number: M00549340 (XMD P/N 70-0050-422) Lot Number: 930141

Lot Numbers:

Number

Part Number: M00549480 (XMD P/N 70-0050-424) Lot Number: 930154

Lot Numbers:

Number

Part Number: M00548260 (XMD P/N 70-0050-512) Lot Number: 929602

Lot Numbers:

Number

Part Number: M00548380 (XMD P/N 70-0050-514) Lot Number: 911109 915409 915909 920609 928910 930840

Lot Numbers:

Number

Part Number: M00548540 (XMD P/N 70-0050-516) Lot Number: 911112 915912 919006 920612 929624

Lot Numbers:

Number

Part Number: M00548700 (XMD P/N 70-0050-518) Lot Number: 928921 929711

Lot Numbers:

Number

Part Number: M00548860 (XMD P/N 70-0050-520) Lot Number: 929728

Lot Numbers:

Number

Part Number: M005489350 (XMD P/N 70-0050-522) Lot Number: 930142

Lot Numbers:

Number

Part Number: M005489490 (XMD P/N 70-0050-524) Lot Number: 930155

Lot Numbers:

Number

Part Number: M00548270 (XMD P/N 70-0050-612) Lot Number: 929603

Lot Numbers:

Number

Part Number: M00548390 (XMD P/N 70-0050-614) Lot Number: 928911

Lot Numbers:

Number

Part Number: M00548550 (XMD P/N 70-0050-616) Lot Number: 928917 929625

Lot Numbers:

Number

Part Number: M00548710 (XMD P/N 70-0050-618) Lot Number: 928922 929712

Lot Numbers:

Number

Part Number: M00548870 (XMD P/N 70-0050-620) Lot Number: 929729

Lot Numbers:

Number

Part Number: M00549360 (XMD P/N 70-0050-622) Lot Number: 930143

Lot Numbers:

Number

Part Number: M00549500 (XMD P/N 70-0050-624) Lot Number: 930156

Lot Numbers:

Number

Part Number: M00548280 (XMD P/N 70-0050-712) Lot Number: 929604

Lot Numbers:

Number

Part Number: M00548400 (XMD P/N 70-0050-714) Lot Number: 928912

Lot Numbers:

Number

Part Number: M00548560 (XMD P/N 70-0050-716) Lot Number: 929626

Lot Numbers:

Number

Part Number: M00548720 (XMD P/N 70-0050-718) Lot Number: 928923 929713

Lot Numbers:

Number

Part Number: M00548880 (XMD P/N 70-0050-720) Lot Number: 930129

Lot Numbers:

Number

Part Number: M00549370 (XMD P/N 70-0050-722) Lot Number: 930144

Lot Numbers:

Number

Part Number: M00549510 (XMD P/N 70-0050-724) Lot Number: 930827

Lot Numbers:

Number

Part Number: M00548290 (XMD P/N 70-0050-812) Lot Number: 929605

Lot Numbers:

Number

Part Number: MM00548410 (XMD P/N 70-0050-814) Lot Number: 929609

Lot Numbers:

Number

Part Number: M00548570 (XMD P/N 70-0050-816) Lot Number: 929622

Lot Numbers:

Number

Part Number: M00548890 (XMD P/N 70-0050-820) Lot Number: 923308

Lot Numbers:

Number

Part Number: M00549380 (XMD P/N 70-0050-822) Lot Number: 930145

Lot Numbers:

Number

Part Number: M00549520 (XMD P/N 70-0050-824) Lot Number: 930828

Lot Numbers:

Number

Part Number: M00548300 (XMD P/N 70-0050-912) Lot Number: 929606

Lot Numbers:

Number

Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00548420 (XMD P/N 70-0050-914)

Part Number: M00548420 (XMD P/N 70-0050-914) Lot Number: 929610

Lot Numbers:

Number

Part Number: M00548580 (XMD P/N 70-0050-916) Lot Number: 929623

Lot Numbers:

Number

Part Number: M00548740 (XMD P/N 70-0050-918) Lot Number: 929715

Lot Numbers:

Number

Part Number: M00548900 (XMD P/N 70-0050-920) Lot Number: 930130

Lot Numbers:

Number

Part Number: M00549390 (XMD P/N 70-0050-922) Lot Number: 930146

Lot Numbers:

Number

Part Number: M00549390 (XMD P/N 70-0050-922) Lot Number: 930841

Lot Numbers:

Number

Part Number: M00548310 (XMD P/N 70-0050-A12) Lot Number: 929607

Lot Numbers:

Number

Part Number: M00548430 (XMD P/N 70-0050-A14) Lot Number: 929611

Lot Numbers:

Number

Part Number: M00548590 (XMD P/N 70-0050-A16) Lot Number: 929701

Lot Numbers:

Number

Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00548750 (XMD P/N 70-0050-A18)

Part Number: M00548750 (XMD P/N 70-0050-A18) Lot Number: 929716

Lot Numbers:

Number

Part Number: M00548910 (XMD P/N 70-0050-A20) Lot Number: 930131

Lot Numbers:

Number

Part Number: M00549400 (XMD P/N 70-0050-A22) Lot Number: 930147

Lot Numbers:

Number

Part Number: M00549540 (XMD P/N 70-0050-A24) Lot Number: 930829

Lot Numbers:

Number

Part Number: M00548320 (XMD P/N 70-0050-B12) Lot Number: 929608

Lot Numbers:

Number

Part Number: M00548440 (XMD P/N 70-0050-B14) Lot Number: 929612

Lot Numbers:

Number

Part Number: M00548600 (XMD P/N 70-0050-B16) Lot Number: 929702

Lot Numbers:

Number

Part Number: M00548760 (XMD P/N 70-0050-B18) Lot Number: 929717

Lot Numbers:

Number

Part Number: M00M00548920 (XMD P/N 70-0050-B20) Lot Number: 929132

Lot Numbers:

Number

Part Number: M00549410 (XMD P/N 70-0050-B22) Lot Number: 930148

Lot Numbers:

Number

Part Number: M00549550 (XMD P/N 70-0050-B24) Lot Number: 930834

Lot Numbers:

Number

Part Number: M00548450 (XMD P/N 70-0050-C14) Lot Number: 929613

Lot Numbers:

Number

Part Number: M00548610 (XMD P/N 70-0050-C16) Lot Number: 929703

Lot Numbers:

Number

Part Number: M00548770 (XMD P/N 70-0050-C18) Lot Number: 929718

Lot Numbers:

Number

Part Number: M00548930 (XMD P/N 70-0050-C20) Lot Number: 930133

Lot Numbers:

Number

Part Number: M00549420 (XMD P/N 70-0050-C22) Lot Number: 923309

Lot Numbers:

Number

Part Number: M00549560 (XMD P/N 70-0050-C24) Lot Number: 930830

Lot Numbers:

Number

Part Number: M00548460 (XMD P/N 70-0050-D14) Lot Number: 929614

Lot Numbers:

Number

Part Number: M00548620 (XMD P/N 70-0050-D16) Lot Number: 929704

Lot Numbers:

Number

Part Number: M00548780 (XMD P/N 70-0050-D20) Lot Number: 929720

Lot Numbers:

Number

Part Number: M00549430 (XMD P/N 70-0050-D22) Lot Number: 930149

Lot Numbers:

Number

Part Number: M00549570 (XMD P/N 70-0050-D24) Lot Number: 930831

Lot Numbers:

Number

Part Number: M00548470 (XMD P/N 70-0050-E14) Lot Number: 929615

Lot Numbers:

Number

Part Number: M00548630 (XMD P/N 70-0050-E16) Lot Number: 929705

Lot Numbers:

Number

Part Number: M00548790 (XMD P/N 70-0050-E18) Lot Number: 929721

Lot Numbers:

Number

Part Number: M00548950 (XMD P/N 70-0050-E20) Lot Number: 930135

Lot Numbers:

Number

Part Number: M00549440 (XMD P/N 70-0050-E22) Lot Number: 930150

Lot Numbers:

Number

Part Number: M00549580 (XMD P/N 70-0050-E24) Lot Number: 930832

Lot Numbers:

Number

Part Number: M00548480 (XMD P/N 70-0050-F14) Lot Number: 929616

Lot Numbers:

Number

Part Number: M00548640 (XMD P/N 70-0050-F16) Lot Number: 929706

Lot Numbers:

Number

Part Number: M00548800 (XMD P/N 70-0050-F18) Lot Number: 929722

Lot Numbers:

Number

Part Number: M00548960 (XMD P/N 70-0050-F20) Lot Number: 930136

Lot Numbers:

Number

Part Number: M00549450 (XMD P/N 70-0050-F22) Lot Number: 930151

Lot Numbers:

Number

Part Number: M00549590 (XMD P/N 70-0050-F24) Lot Number: 930833

Lot Numbers:

Number

Part Number: M00548490 (XMD P/N 70-0050-G14) Lot Number: 929617

Lot Numbers:

Number

Part Number: M00548650 (XMD P/N 70-0050-G16) Lot Number: 929707

Lot Numbers:

Number

Part Number: M00548810 (XMD P/N 70-0050-G18) Lot Number: 929723

Lot Numbers:

Number

Part Number: M00548970 (XMD P/N 70-0050-G20) Lot Number: 930137

Lot Numbers:

Number

Part Number: M00549460 (XMD P/N 70-0050-G22) Lot Number: 930152

Lot Numbers:

Number

Part Number: M00549600 (XMD P/N 70-0050-G24) Lot Number: 923310

Lot Numbers:

Number

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 73024

Status: Resolved

Manufacturer: Xeridiem Mediem Medical Devices Inc

Manufactured In: United States