WalkMed Infusion, LLC: WalkMed Infusion, LLC Announces a Voluntary Field Action of Multiple Triton Administration Sets Due to the Potential Presence of Particulate In or On the Administration Sets.

Agency Publication Date: July 18, 2016

Affected Products

Product: Spike Set, 12" Microbore SPM-12. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.

Product Number: 020-204840. Lot Number: 1504031D

Lot Numbers:

Number

Product: T030-000 -30" 20 Drop IV Admin Secondary Set. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.

Product Number: 020-300188. Lot Number: 1407012, 1407013, 1407504, 1408125, 1410069D, 1410070D, 1410071D, 1411106D, 1412002D, 1412113D, 1503120D, 1506053D, 1507011D

Lot Numbers:

Number

Product: T090-000 90" 20 Drop IV Admin Set. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.

Product Number: 020-300197. Lot Number: 1406082, 1407122, 1408126, 1408128, 1410078D, 1410079D, 1410080D, 1410081D, 1410082D, 1411025D, 1411026D, 1501022D, 1501109D, 1503083D, 1507012D

Lot Numbers:

Number

Product: T090-000V 90" 20 Drop IV Admin Set w/ Needlefree Y-Site. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.

Product Number: 020-300198. Lot Number: 1406083, 1406084, 1406085, 1406086, 1407014, 1407015, 1407118, 1407119, 1408129, 1408130, 1410072D, 1410073D, 1412059D, 1501062D, 1501106D, 1503048D, 1503049D, 1506064D

Lot Numbers:

Number

Product: T090-000W 90" 20 Drop IV Admin Set w/2 Needlefree Y-Sites Back Check Valve. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.

Product Number: 020-300204. Lot Number: 1406006, 1406008, 1406170, 1406171, 1406172, 1406173, 1406174, 1407125, 1407126, 1407127, 1407128, 1407129, 1408076, 1408077, 1409038D, 1409039D, 1409040D, 1410074D, 1410075D, 1410076D, 1410077D, 1411066D, 1411067D, 1412003D, 1412004D, 1412006D, 1412007D, 1501054D, 1501055D, 1501056D, 1501057D, 1501058D, 1502023D, 1502025D, 1502033D, 1503051D, 1503053D, 1506055D, 1506057D

Lot Numbers:

Number

Product: T090-022V 90" 20 Drop IV Admin Set Needle free Y-Site & 0.22 Fltr. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.

Product Number: 020-300206. Lot Number: 1406087, 1407505, 1409132D, 1409133D, 1412060D, 1503090D

Lot Numbers:

Number

Product: T095-022, IV Set with 0.22 Micron Filter. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.

Product Number: 020-300576. Lot Number: 1407016, 1410164D, 1411070D, 1501024D, 1503091D, 1506091D

Lot Numbers:

Number

Product: T095-120 IV Set with 1.2 Micron Filter. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.

Product Number: 020-300577. Lot Number: 1407025

Lot Numbers:

Number

Product: T100-000F, 100" IV Set with Free Flow Clip. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.

Product Number: 020-300642. Lot Number: 1406088, 1406163, 1406164, 1406165, 1409041D, 1409134D, 1410165D, 1506065D, 1508008D

Lot Numbers:

Number

Product: T100-000VF, IV Set with Lower Y Site and Free Flow Clip. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.

Product Number: 020-300643. Lot Number: 1406089, 1407017, 1407018, 1407019, 1407506, 1408132, 1412071D, 1412114D, 1501110D, 1503055D, 1506066D, 1508007D

Lot Numbers:

Number

Product: T100-000WF, IV Set with Upper Y-Site, Lower Y-Site, Back Check Valve, and Free Flow Clip. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.

Product Number: 020-300644. Lot Number: 1406019, 1406020, 1407020, 1407021, 1407022, 1407120, 1407121, 1408133, 1501111D, 1506067D, 1507020D, 1507060D, 1508073D

Lot Numbers:

Number

Product: T100-022F with 0.22 micron filter and FP Clip. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.

Product Number: 020-300649. Lot Number: 1412061D, 1503069D, 1505046D, 1506087D

Lot Numbers:

Number

Product: T100-120F with 1.2 micron filter and FP Clip. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.

Product Number: 020-300650. Lot Number: 1412070D, 1502055D, 1503039D, 1505047D, 1506051D, 1506052D

Lot Numbers:

Number

Product: T105-000WC IV Set w/2 Y-Sites, BC Vlv & Filter Cap. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.

Product Number: 020-300692. Lot Number: 1407023, 1409042D, 1410166D, 1411072D, 1412062D

Lot Numbers:

Number

Product: T100-022WF, IV Set with 2 Y-Sites, 0.22 micron filter, Back Check Valve, & FP Clip. Packaged in a Tyvek pouch, with 50 pouches per case. Product Usage: Used to administer fluids from a container to a patient through a needle or catheter inserted into a vein.

Product Number: 020-300828. Lot Number: 1406166, 1406167, 1406168, 1406169, 1407507, 1408134

Lot Numbers:

Number

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 74437

Status: Resolved

Manufacturer: WalkMed Infusion, LLC

Manufactured In: United States

Units Affected: 15 products (37 cases; 2453 cases; 2757 cases; 3342 cases; 7529 cases; 679 cases; 304 cases; 58 cases; 1323 cases; 1857 cases; 2198 cases; 383 total cases; 295 cases; 270 cases; 1147 cases)

Were You Affected by This Recall?

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Sources: FDA iRES · Raw API Response

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Affected Products

Product Number: 020-204840. Lot Number: 1504031D

Lot Numbers:

Number

Product Number: 020-300188. Lot Number: 1407012, 1407013, 1407504, 1408125, 1410069D, 1410070D, 1410071D, 1411106D, 1412002D, 1412113D, 1503120D, 1506053D, 1507011D

Lot Numbers:

Number

Product Number: 020-300197. Lot Number: 1406082, 1407122, 1408126, 1408128, 1410078D, 1410079D, 1410080D, 1410081D, 1410082D, 1411025D, 1411026D, 1501022D, 1501109D, 1503083D, 1507012D

Lot Numbers:

Number

Lot Numbers:

Number

Lot Numbers:

Number

Product Number: 020-300206. Lot Number: 1406087, 1407505, 1409132D, 1409133D, 1412060D, 1503090D

Lot Numbers:

Number

Product Number: 020-300576. Lot Number: 1407016, 1410164D, 1411070D, 1501024D, 1503091D, 1506091D

Lot Numbers:

Number

Product Number: 020-300577. Lot Number: 1407025

Lot Numbers:

Number

Product Number: 020-300642. Lot Number: 1406088, 1406163, 1406164, 1406165, 1409041D, 1409134D, 1410165D, 1506065D, 1508008D

Lot Numbers:

Number

Product Number: 020-300643. Lot Number: 1406089, 1407017, 1407018, 1407019, 1407506, 1408132, 1412071D, 1412114D, 1501110D, 1503055D, 1506066D, 1508007D

Lot Numbers:

Number

Product Number: 020-300644. Lot Number: 1406019, 1406020, 1407020, 1407021, 1407022, 1407120, 1407121, 1408133, 1501111D, 1506067D, 1507020D, 1507060D, 1508073D

Lot Numbers:

Number

Product Number: 020-300649. Lot Number: 1412061D, 1503069D, 1505046D, 1506087D

Lot Numbers:

Number

Product Number: 020-300650. Lot Number: 1412070D, 1502055D, 1503039D, 1505047D, 1506051D, 1506052D

Lot Numbers:

Number

Product Number: 020-300692. Lot Number: 1407023, 1409042D, 1410166D, 1411072D, 1412062D

Lot Numbers:

Number

Product Number: 020-300828. Lot Number: 1406166, 1406167, 1406168, 1406169, 1407507, 1408134

Lot Numbers:

Number

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 74437

Status: Resolved

Manufacturer: WalkMed Infusion, LLC

Manufactured In: United States