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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Maquet Cardiovascular, LLC: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured

Agency Publication Date: May 31, 2019
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Affected Products

Product: Maquet Getinge-BEQ-TOP 15705 Material: 701051122

Batch Numbers: 3000044566 3000046394 3000049202 3000054550 3000058043 3000060239 3000066276 3000069368 3000071833 3000074339 3000080701 3000081598

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-TOP 22702 ECC W/HMOD 30000 Material: 701051179

Batch Numbers: 3000045170 3000058051 3000062455 3000065508

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-TOP 7005 UAMC Pediatric ECC Pack Material: 701051515

Batch Numbers: 3000041127 3000049458 3000061103 3000065550 3000071378 3000075338 3000081601

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-TOP 5502 ECC Pack Material: 701051791

Batch Numbers: 3000043651 3000047320 3000062721 3000064716 3000072309

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-TOP 1601#QUADROX iD - Pack Material:701052285

Batch Numbers: 3000048235 3000056129 3000059730 3000065496 3000070700 3000073428

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-TOP 27901 SMALL PATIENT CI Material:701052287

Batch Numbers: Batch 3000065552 3000070971 3000074623 3000076634 3000080868

Lot Numbers:
Numbers
3000065552
Product: Maquet Getinge-BO-T 6600 TUBING PACK Material:701052324

Batch Numbers: 3000073972

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-TOP 25500 ECC 3/8 w/QiD Material: 701052461

Batch Numbers: 3000065224 3000074124

Lot Numbers:
Numbers
Product: Maquet Getinge-BO-TOP 30300 Material:701052623

Batch Numbers: 3000043293 3000045086 3000050830 3000058048

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-TOP 31000 PEDIATRIC ECC Material:701052843

Batch Numbers: 3000058044 3000062463 3000075430

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-TOP 32200 ECC PACK - Material: 701053319

Batch Numbers: 3000043054 3000049462 3000058326 3000062722 3000069369 3000073168

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-T 8805 ECC PACK Material: 701053361

Batch Numbers: 3000071966 3000074121 3000075280 3000077082

Lot Numbers:
Numbers
Product: Maquet Getinge-BO-TOP 20705 SMALL PATIENT 1/4 Material: 701053486

Batch Numbers: 3000048716 3000054549 3000061302 3000067224 3000070815 3000072509 3000076464

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-TOP 33500 3/8" ECC PACK Material: 701053752

Batch Numbers: 3000056255

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-TOP 33501 1/4" ECC PACK Material: 701053754

Batch Numbers: 3000054158

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-TOP 33700 ECC 3/8" PACK Material: 701053845

Batch Numbers: 3000048232 3000049610 3000056811 3000063949 3000067795 3000071203 3000071783

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-TOP 25001 MONTEFIORE Material: 701053906

Batch Numbers: 3000054551 3000065085

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-TOP 33704 ECC 1/4" PACK Material: 701054150

Batch Numbers: 3000049611 3000058052 3000062459 3000066196

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-TOP 24202 ADULT ECC Material:701054295

Batch Numbers: 3000057379 3000063707 3000066885 3000071785 3000071806 3000073164

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-TOP 32100 ADULT CUSTOM PAC Material:701054438

Batch Numbers: 3000043291 3000044425 3000046811 3000047912 3000052203 3000053795 3000059174 3000062478 3000066197 3000067469 3000070703 3000074122 3000075896

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-TOP 21503 ECC 1/4" AV LOOP Material:701054776

Batch Numbers: 3000043295 3000047248 3000047254 3000055638 3000062271 3000065551 3000069074 3000075386

Lot Numbers:
Numbers
Product: Maquet Getinge-BO-TOP 13901 RAPID RESPONSE Material:701054874

Batch Numbers: 3000044426 3000049067 3000053796 3000054622 3000067221 3000067796 3000072147 3000074175

Lot Numbers:
Numbers
Product: Maquet Getinge-T 22706 SAMPLE MANIFOLD Material:701054912

Batch Numbers: 3000055636

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-T 8025 1/4" ECC Pack with RF32 Material:701055142

Batch Numbers: 3000044427 3000054806 3000059172 3000069470

Lot Numbers:
Numbers
Product: Maquet Getinge-BO-TOP 30901 CUSTOM CPB PACK Material: 701055372

Batch Numbers: 3000061506

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-TOP 37200 CIRCULATORY CIRC Material: 701055388

Batch Numbers: 3000044291 3000046812 3000048395 3000051270 3000054144 3000055979 3000058735 3000061304 3000063708 3000066691 3000070702 3000072307 3000075122

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-TOP 37500 ECC QUADROX ID Material: 701055601

Batch Numbers: 3000048238 3000061109 3000069075

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-TOP 38002 ADULT SPECIALTY Material:

Batch Numbers: 3000055504

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-TOP 38300 ADULT CPS QID Material: 701055862

Batch Numbers: 3000047632 3000052206 3000055637 3000060482 3000067466

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-TOP 38302 INFANT CPS QPID Material: 701055866

Batch Numbers: 3000045221 3000049201 3000054750 3000062046 3000065497 3000067793 3000069723 3000072247 3000075339 3000080720 3000084636

Lot Numbers:
Numbers
Product: Maquet Getinge-T 8028 PRESSURE PIGTAIL 4" Material: 701055993

Batch Numbers: 3000054751 3000055509 3000061510 3000066891 3000075388 3000080435 3000080699 3000081533

Lot Numbers:
Numbers
Product: Maquet Getinge-T 8029 PRESSURE PIGTAIL 6" Material: 701055995

Batch Numbers: 3000058045 3000069467 3000072507 3000080702

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-T 4906 PEDIARIC CPB PACK Material: 701056041

Batch Numbers: 3000041540

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-TOP 38900 ECC PACK Material: 701056368

Batch Numbers: 3000041396 3000044053 3000047317 3000050887 3000058131 3000060487 3000060723 3000062458 3000064724 3000071815 3000071817

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-TOP 26402 ECC PACK Material: 701062310

Batch Numbers: 3000043296 3000046809 3000047251 3000050480 3000054805 3000060727 3000066887

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-T 39700 ECC PACK Material:701062473

Batch Numbers: 3000045173 3000046396 3000046746

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-TOP 2202 NEONATAL SPECIALT Material:701062613

Batch Numbers: 3000041407 3000069806

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-TOP 40700 HUNTINGTON Material:701062899

Batch Numbers: 3000057630 3000083783

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-TOP 30901 CUSTOM CPB PACK Material:701063071

Batch Numbers: 3000044877 3000045089 3000045951

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-TOP 41200 ECC 1/4 PUMP PAC Material: 701063149

Batch Numbers: 3000064725

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-TOP 25003 3/8X3/8 TO 7LPM Material: 701063255

Batch Numbers: 3000041007 3000044052 3000045730 3000047318 3000054334 3000054615 3000063091

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-TOP 21506 ECC PACK Material:701064505

Batch Numbers: 3000046810 3000054159 3000066889 3000074123

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-T 5211 LARGE ECC SET Material:701064560

Batch Numbers: Batch 3000041128 3000045731 3000050577 3000052947 3000054617 3000054955 3000057631 3000071818

Lot Numbers:
Numbers
3000041128
Product: Maquet Getinge-BEQ-T 5908 TCH HLS ANCILLARY Material: 701064590

Batch Numbers: 3000071399

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-T 30601 CMC ACCESSORY KIT Material: 701064701

Batch Numbers: 3000054160 3000057639 3000058046

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-TOP 24105 ECC PACK Material:701064757

Batch Numbers: 3000051271 3000057632 3000062460 3000066202 3000069076 3000073425 3000076761 3000080703

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-T 27904 3/8 TRANSPORT PACK Material:701064804

Batch Numbers: 3000057680 3000066687 3000075125 3000075898 3000080799

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-TOP 44701 PEDIATRIC ECC Material: 701064825

Batch Numbers: 3000071198

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-T 44200 MAYO PULMONARY P Material: 701064831

Batch Numbers: 3000066688 3000080800

Lot Numbers:
Numbers
Product: Maquet Getinge-BO-T 44201 MAYO PULMONARY PACK Material: 701064834

Batch Numbers: 3000041415 3000044885 3000077738

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-TOP 41201 ECC 3/8 PUMP PAC Material: 701064867

Batch Numbers: 3000045174 3000049559 3000057376 3000063289 3000069864 3000074097

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-T 8069 Pediatric Pack Material: 701064965

Batch Numbers: 3000046123 3000059176

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-TOP 5909 1/4 PACK W QPID Material: 701064992

Batch Numbers: 3000043679 3000047252 3000050833 3000053134 3000054956 3000056048 3000060481 3000063710 3000067185 3000071400 3000073429 3000075387 3000075899

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-TOP 37302 Quadrox iD Pediatric Pack Material: 701065190

Batch Numbers: 3000069382 3000074502

Lot Numbers:
Numbers
Product: Maquet Getinge-BO-T 41301 BUMC ECC PACK Material: 701065209

Batch Numbers: 3000049454 3000054311 3000054314 3000055640

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-TOP 27609 ECC PACK 1/4" Material: 701065504

Batch Numbers: 3000044419 3000045727 3000065141

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-TOP 31203 CUSTOM PACK NEO Material: 701065510

Batch Numbers: 3000050481 3000052617 3000054413 3000054961 3000055976

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-TOP 31204 CUSTOM PACK PEDI Material: 701065512

Batch Numbers: 3000056132

Lot Numbers:
Numbers
Product: Maquet Getinge-BO-T 46200 3/16" x 1/4" Neonate Pack Material: 701065620

Batch Numbers: 3000043297 3000045729 3000046485 3000049608 3000052615 3000054322 3000056259 3000062050

Lot Numbers:
Numbers
Product: Maquet Getinge-BO-TOP 36504 ADULT ECC PACK Material: 701065765

Batch Numbers: 3000043680 3000046039 3000049205 3000052613 3000055536 3000062791

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-TOP 30907 ECC PUMP PACK Material: 701065770

Batch Numbers: 3000041328 3000041619

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-T 46500 PRIME PACK Material:701065823

Batch Numbers: 3000043849 3000046392

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-T 16405 LIVER TX INFUSION Material:701066097

Batch Numbers: 3000055324 3000061509

Lot Numbers:
Numbers
Product: Maquet Getinge-BO-T 41302 PRIMING LINES BUMC Material:701066291

Batch Numbers: 3000062472 3000071380

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-T 9405 LARGE PATIENT TBG P Material:701066366

Batch Numbers: 3000044415 3000046393 3000046736

Lot Numbers:
Numbers
Product: Maquet Getinge-T 41303 AV MANIFOLD FOR ECC PA Material:701066551

Batch Numbers: 3000041542 3000046483 3000049065 3000055328 3000057682 3000060483 3000063712

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-TOP 47800 STRINGFELLOW PED Material:701066583

Batch Numbers: 3000046122 3000062040

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-T 4903 Mercy Med w/o Oxy Material:701066664

Batch Numbers: 3000041468 3000053105 3000054552 3000057683 3000059795 3000065086 3000067186 3000069077 3000071375 3000072684 3000074341 3000075431 3000078942 3000080722 3000081524 3000084050

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-T 8068 1/4" WITH BRIDGE Material: 701066883

Batch Numbers: 3000041327 3000042148 3000042819 3000046732 3000054315 3000055642 3000062038 3000066689

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-T 4963 CARDIOPLEGIA PACK Material: 701067203

Batch Numbers: 3000053530 3000058323

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-T 49002 ROTAFLOW SUPPORT PACK Material: 701067280

Batch Numbers: 3000044421

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-TOP 5208 ECC SET CARDIAC Material: 701067350

Batch Numbers: 3000044413 3000049064 3000050885 3000054157 3000058832 3000062461 3000065084

Lot Numbers:
Numbers
Product: Maquet Getinge-BO-TOP 14605 OPEN HEART WITHOU Material: 701067372

Batch Numbers: 3000047035 3000051157 3000056254 3000059729 3000062036 3000063395

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-T 37305 1/4+3/8 TABLE LINE Material: 701067577

Batch Numbers: 3000066690 3000072826 3000080852

Lot Numbers:
Numbers
Product: Maquet Getinge-BO-TOP 35503 SGD PACK Material: 701067668

Batch Numbers: 3000056047 3000058250 3000066199

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-TOP 50100 CHOSA 1/4" ECC PACK Material: 701067837

Batch Numbers: 3000041469

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-T 3501 LVAD/ 3/8" Material: 701068008

Batch Numbers: 3000042629 3000057758

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-T 3502 LVAD 1/4" Material: 701068168

Batch Numbers: 3000042630 3000053054 3000054960 3000058830

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-TOP 8207 1/4" ECC PACK Material: 701068395

Batch Numbers: 3000044423

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-TOP 35503 SGD Pack Material: 701068797

Batch Numbers: 3000048720 3000058736 3000063950 3000070973 3000072680 3000075283

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-TOP 8208#3/8 inch ECC Pack Material: 701068798

Batch Numbers: 3000042989 3000058142

Lot Numbers:
Numbers
Product: Maquet Getinge-BO-T 2303 Small Adult Cardiac Surgery Material:709000004

Batch Numbers: 3000045083 3000046399

Lot Numbers:
Numbers
Product: Maquet Getinge-BO-T 2302 Pediatric Cardiac Surgery Pack Material: 709000006

Batch Numbers: 3000059175

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-T 30914 ECC Pump Pack 1/4" Material: 709000011

Batch Numbers: 3000064952

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-TOP 49103 ECC Pack 0 No Bladder Material: 709000058

Batch Numbers: 3000043158 3000045091 3000046739 3000050831 3000062044 3000065548

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-T 28906 1/4" with Bridge Ancillary P Material: 709000072

Batch Numbers: 3000062737 3000068119

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-TOP 50903 Custom ECC Pack-Pedriatric Material: 709000078

Batch Numbers: 3000047631 3000054421 3000063290 3000071804 3000073166 3000075337

Lot Numbers:
Numbers
Product: Maquet Getinge-BO-TOP 28903 Adult ECC Pack Material: 709000093

Batch Numbers: 3000045728 3000051160 3000058050

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-T 51501 Ochsner ECC Pack Material:709000113

Batch Numbers: 3000060038

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-T 51502 Ochsner ECC Ancillary Pack Material:709000115

Batch Numbers: 3000043613 3000076067

Lot Numbers:
Numbers
Product: Maquet Getinge-BO-T 52360 Cardioplegia Pack Material: 709000127

Batch Numbers: 3000053531 3000060033 3000067120

Lot Numbers:
Numbers
Product: Maquet Getinge-BO-T 46201 Small Pediatric Cardiac Surge Material: 709000133

Batch Numbers: 3000044424 3000046488 3000049459 3000055093 3000060357

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-T 8506 Transport Pack Material: 709000146

Batch Numbers: 3000075713

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-T 53400 Adaption Pack Material: 709000213

Batch Numbers: 3000047192 3000049558 3000067521

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-T 52301 ¿ Sash & Accessory Pack Material: 709000266

Batch Numbers: 3000044290 3000046395

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-T 5915 TCH 3/8 Inch Change Kit Material: 709000280

Batch Numbers: 3000071199 3000081153

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-T 5914 TCH ¿ Inch Change Kit Material: 709000334

Batch Numbers: 3000071200 3000081154 3000084780

Lot Numbers:
Numbers
Product: Maquet Getinge-T 8030 4 in High Flow Pigtail Material: 709000366

Batch Numbers: 3000065493

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-T 4917 Mercy Medical Versa-Pack Material: 709000368

Batch Numbers: 3000043162

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-T 25501 3/8" Better Bladder Pack Material: 709000370

Batch Numbers: 3000048718 3000052045 3000060037 3000074174

Lot Numbers:
Numbers
Product: Maquet Getinge-BO-T 51502 Ochsner ECC Adult Pack Material: 709000385

Batch Numbers: 3000048398 3000075385 3000075472

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-T 36507 Accessory Pk Mercy Material: 709000390

Batch Numbers: 3000048719 3000062269 3000074321 3000077543

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-T 27602 709000417 Adult Custom Pack Material: 709000417

Batch Numbers: 3000061104

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-T 57000 Rotaflow Pack Material: 709000424

Batch Numbers: 3000065091

Lot Numbers:
Numbers
Product: Maquet Getinge-T 5220 UAB Hospital Accessory Material: 709000426

Batch Numbers: 3000054667 3000067797 3000073970 3000076941

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-T 9409 Lurie Chlds Large 3/8 Material: 709000428

Batch Numbers: 3000061513 3000071803 3000075279 3000077546

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-T 9410 Lurie Chldns Small 1/4 Material: 709000430

Batch Numbers: 3000060035 3000065494 3000067883 3000071809 3000074480 3000075340 3000077550

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-T 25502 1/4 Better Bladder Material: 709000434

Batch Numbers: 3000059445 3000062029 3000062476 3000080867

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-T 48002 Bridge Kit Material: 709000444

Batch Numbers: 3000058085

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-TOP 8075 S-Quadrox iD Plus Pack wRF3 Material: 709000460

Batch Numbers: 3000081747

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-TOP 25503 TMC ¿ with BB & QiD Pedi Material:709000473

Batch Numbers: 3000074399

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-T 48003 Rotaflow ONLY Support Pack Material:709000490

Batch Numbers: 3000074503 3000078944 3000081155

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-TOP 31603 CHKD 3/8" ECC Material: 709000516

Batch Numbers: 3000083879

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-TOP 31604 CHKD 1/4" ECC Material: 709000518

Batch Numbers: 3000083880

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-T 4932 Mercy Adaptation Pk Pediatric Material:709000520

Batch Numbers: 3000079888 3000081748

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-TOP 8013 ECC QUADROX iD Pack RF32 Material:701047962R01

Batch Numbers: 3000078425

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-TOP 5103 CPS Tubing Pack Material:701048690R01

Batch Numbers: 3000077756 3000078014

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-TOP 17207 3/8" ECC Pack Material:701049346R01

Batch Numbers: 3000079611

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-TOP 22600 ECC QUADROX ID 3 Material:701049440R01

Batch Numbers: 3000053103 3000066198 3000071830 3000073677

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-TOP 22600 ECC QUADROX iD 3/8 Material:701049440R02

Batch Numbers: 3000076147

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-TOP 21502 ECC Quadrox iD w/RF 3/8" Material:701050060R01

Batch Numbers: 3000079889

Lot Numbers:
Numbers
Product: Maquet Getinge- BEQ-TOP 24100 Small Patient ECC Pack Material:701050175R02

Batch Numbers: 3000041467 3000050581 3000055641 3000060358 3000067467 3000073974 3000083165

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-TOP 24101 Adult ECC Pack Material:701050177R01

Batch Numbers: 3000042145 3000056049

Lot Numbers:
Numbers
Product: Maquet Getinge- BEQ-TOP 5900 TCH 3/8 Quadrox-iD Pack Material:701050228R01

Batch Numbers: 3000077553 3000084779

Lot Numbers:
Numbers
Product: Maquet Getinge-BO-TOP 15200 OR PACK HMO & RF Material:701050647R01

Batch Numbers: 3000045166 3000050578 3000054620

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-TOP 15704 Circulatory Circuit 3/8" Material:701050859R01

Batch Numbers: 3000077742

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-TOP 5502 ECC Pack Material:701051791R01

Batch Numbers: 3000074733 3000081599

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-TOP 28601 NEONATE ECC QPiD Material: 701051935R01

Batch Numbers: 3000046120 3000062048 3000068120

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-TOP 25500 ECC 3/8 in AV Loop w Qx-iD Material: 701052461R01

Batch Numbers: 3000079891

Lot Numbers:
Numbers
Product: Maquet Getinge- BEQ-TOP 32200 ECC Pack Material: 701053319R01

Batch Numbers: 3000077744

Lot Numbers:
Numbers
Product: Maquet Getinge-BO-TOP 20705 SMALL PATIENT 1/4 Material: 701053486R01

Batch Numbers: 3000080434 3000081004

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-TOP 250011/4 1/4 Less than 20 kg up Material: 701053906R01

Batch Numbers: 3000068802 3000071398 3000074190 3000076543

Lot Numbers:
Numbers
Product: Maquet Getinge: (1) Material: 701053941R01 BEQ-TOP 9005 3/8 Custom Pk w/RF32 & HMOD (2) Material: 701053941R02- BEQ-TOP 9005 3/8 Custom Pk w RF32 & HMOD Material:

Batch Numbers: (1) 3000051652 3000054808 3000058733 3000062473 3000071201 3000073170 3000075123 (2) 3000076148 3000081600

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-TOP 24202 ADULT ECC Material: 701054295R01

Batch Numbers: 3000080713

Lot Numbers:
Numbers
Product: Maquet Getinge- BEQ-TOP 27700 Quadrox iD Pack Material: 701054389R02

Batch Numbers: 3000049066 3000053533

Lot Numbers:
Numbers
Product: Maquet Getinge- BEQ-TOP 32100 Adult Custom Pack Material:701054438R01

Batch Numbers: 3000077084 3000084911

Lot Numbers:
Numbers
Product: Maquet Getinge-BEQ-TOP 9004 1/4 Custom Pk w/RF32 & HMOD Material: 701054451R01

Batch Numbers: 3000050941 3000053625 3000069865 3000071831 3000080721 3000083489

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Product: Maquet Getinge- BO-TOP 13901 Rapid Response Universal Pk Material: 701054874R01

Batch Numbers: 3000077890 3000079608

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Product: Maquet Getinge- BEQ-TOP 37200 E-Circuit Bioline Heparin Material: 701055388R01

Batch Numbers: 3000076762 3000077899 3000078013 3000084649

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Product: Maquet Getinge- (1) Material: 701055490R01 BEQ-TOP 15801 ¿ inch ECC Pack (2) Material :701055490R02 BEQ-TOP 15801 1/4 in ECC Pack

Batch Numbers: (1) 3000050886 (2) 3000066508, 3000081906

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Product: Maquet Getinge- BEQ-TOP 5210 ECC Set - Respiratory Material: 701055604R01

Batch Numbers: 3000044876 3000047906 3000051750 3000056130 3000061303 3000062457 3000071820

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Product: Maquet Getinge BEQ-TOP 38300 ADULT CPS QID Material:701055862R01

Batch Numbers: 3000074735 3000080798

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Product: Maquet Getinge- BEQ-TOP 28901 MCV INFANT ECC Material:701056771R01

Batch Numbers: 3000046112 3000051162 3000056133 3000062045 3000071402 3000074895 3000075715 3000078940

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Product: Maquet Getinge- BEQ-T 39700 ECC Pack Material:701062473R01

Batch Numbers: 3000056807 3000058047 3000061214 3000064945 3000068116 3000071379 3000071832 3000080848 3000081908

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Product: Maquet Getinge- (1) Material: 701063255R01 BEQ-TOP 25003 3/8 3/8 up to 7lpm (2) Material: 701063255R02 BEQ-TOP 25003 3/8 3/8 up to 7 lpm

Batch Numbers: (1)3000070816, 3000072682 (2) 3000074736, 3000077083, 3000080988, 3000082175 ***Updated 3/26/20*** Extended: 3000087051

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Product: Maquet Getinge BO-TOP 48400 OR PACK Material: 701064327R01

Batch Numbers: 3000045085 3000047033 3000051653 3000056258 3000062266

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Product: Maquet Getinge- BEQ-T 5211 ECC Large Children's Hospital Material: 701064560R01

Batch Numbers: 3000068115 3000081002 3000083490

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Product: Maquet Getinge- BEQ-TOP 41201 ECC 3/8 Pump Pack Wake For Material: 701064867R01

Batch Numbers: 3000080724 3000084928

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Product: Maquet Getinge- BO-T 41301 BUMC ECC PACK Material: -701065209R01

Batch Numbers: 3000060743 3000066277 3000069078 3000073171 3000074176 3000076468 3000080999 3000081905 3000085277

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Product: Maquet Getinge- (1)Material: 701065765R01 BO-TOP 36504 Adult ECC Pack (2)Material: 701065765R02 BO-TOP 36504 Adult ECC Pack

Batch Numbers: (1)3000058184, 3000067382, 3000069380, 3000071967, 3000074322 (2)3000077734

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Product: Maquet Getinge- BEQ-TOP 46700 ADULT ECC PACK Material:701065833R01

Batch Numbers: 3000076856 3000077891

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Product: Maquet Getinge-BEQ-TOP 49101 Childrens Large ECC Pack Material: 701067069R01

Batch Numbers: 3000059724

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Product: Maquet Getinge- BEQ-TOP 39202 NICU ECC PACK Material: 701067313R01

Batch Numbers: 3000043846 3000047255 3000052044 3000061508 3000074098 3000078928 3000079607

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Product: Maquet Getinge- (1) Material: 701067350R01 BEQ-TOP 5208 ECC Small-Cardiac (2) material: 701067350R02 BEQ-TOP 5208 ECC Small-Cardiac

Batch Numbers: (1) 3000067384, 3000070970 (2) 3000074734, 3000081003

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Product: Maquet Getinge BEQ-TOP 40010 OPEN HEART PACK Material: -701067364R02

Batch Numbers: 3000058180 3000062474

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Product: Maquet Getinge- (1) Material :701067370R01 BO-TOP 38803 OPEN HEART PACK W (2) Material: 701067370R02 BO-TOP 38803 OPEN HEART PACK W (3) Material: 701067370R03 BO-TOP 38803 OPEN HEART PACK W

Batch Numbers: (1) 3000042627 (2) 3000047034 (3) 3000058143

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Product: Maquet Getinge BEQ-T 3501 LVAD 3/8" Material: 701068008R01

Batch Numbers: 3000074094

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Product: Maquet Getinge-BEQ-T 3502 LVAD 1/4" Material: 701068168R01

Batch Numbers: 3000074095 3000082174

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Product: Maquet Getinge-BEQ-TOP 35503 SGD Pack Material:701068797R01

Batch Numbers: 3000079609

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Product: Maquet Getinge- BO-T 2303 3/8" x 3/8" Adult Pack Material: 709000004R01

Batch Numbers: 3000058327

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Product: Maquet Getinge-BEQ-TOP 50900 Custom ECC Pack-Neonatal ¿ Material: 709000069R02

Batch Numbers: 3000051158 3000061507 3000067518 3000069468

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Product: Maquet Getinge-BEQ-TOP 50903 Custom ECC Pk-Pdtrc 3/8 - Material: 709000078R01

Batch Numbers: 3000078943

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Product: Maquet Getinge BO-TOP 28903 Adult ECC Pack Material: -709000093R01

Batch Numbers: 3000069722

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Product: Maquet Getinge- BEQ-T 53500 Evanston Rotaflow Pack Material:709000215R01

Batch Numbers: 3000045168 3000046484 3000062270 3000064946 3000084054

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Product: Maquet Getinge-BEQ-T 52301 ¿ Sash & Accessory Pack Material:-709000266R01

Batch Numbers: 3000053797 3000057760 3000063952 3000067187 3000069726 3000072683 3000075716

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Product: Maquet Getinge- BEQ-T 9411 Lurie Children's 1/4 ADAPT Material:709000485R01

Batch Numbers: 3000076765

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Product: Maquet Getinge- BEQ-TOP 54500 BSW-McLANE 3/8 Quadrox iD Material:709000496R01

Batch Numbers: 3000077081

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Product: Maquet Getinge-BO-TOP 20700 SMALL PATIENT 3/8 Material: 701050966

Batch Numbers: 3000063810 3000068490 3000071784 3000076463

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Product: Maquet Getinge-BO-TOP 26300 CUSTOM PACK Material: 701050975

Batch Numbers: 3000043848 3000050583 3000050645 3000053626 3000054146

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Product: Maquet Getinge-BEQ-TOP 15800 TUBING PACK Material: 3000065087

Batch Numbers: 3000062267, 3000065087

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Product: Maquet Getinge-BEQ-TOP 8013 ECC QUADROX iD Pack RF32 Material: 701047962

Batch Numbers: 3000047630 3000050482 3000055980 3000060726 3000066813 3000068491 3000070813 3000074323

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Product: Maquet Getinge-BEQ-T 8803#Circ Circuit Small Patient Material: 701048539

Batch Numbers: Batch 3000043059 3000051269 3000067520 3000072508 3000080853

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3000043059
Product: Maquet Getinge-BEQ-TOP 5103#CPS Tubing Pack Material: 701048690

Batch Numbers: 3000044416 3000049077 3000053102 3000054957 3000056257 3000061306 3000070701 3000072685

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Product: Maquet Getinge-BEQ-TOP 17207 3/8 ECC PACK Material: 701049346

Batch Numbers: 3000043292 3000047704 3000050576 3000052263 3000060362 3000065492 3000066201 3000071202

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Product: Maquet Getinge-BEQ-T-22800 Material: 701049506

Batch Numbers: 3000046489 3000055506

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Product: Maquet Getinge-BEQ-TOP 3700 Tubing Pack Material: 701049510

Batch Numbers: 3000069367

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Product: Maquet Getinge-BEQ-T 9403 Small Patient Tubing Pack Material: 701049994

Batch Numbers: 3000041414 3000047036 3000050575 3000051657

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Product: Maquet Getinge-BEQ-TOP 21502# Med City Childr Material: 701050060

Batch Numbers: 3000049556 3000067468

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Product: Maquet Getinge-BEQ-TOP 5900 3/8 Quadrox iD Pack w/BB Material: 701050228

Batch Numbers: 3000048233 3000048397 3000054333 3000058183 3000069469 3000074100

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Product: Maquet Getinge-BEQ-TOP 24500 ADULT ECC Material: 701050253

Batch Numbers: 3000041126 3000053053 3000054958 3000055326 3000064943 3000066814 3000071782

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Product: Maquet Getinge-BEQ-TOP 22701 Material: 701050790

Batch Numbers: 3000060359 3000060495 3000062725 3000071781

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Product: Maquet Getinge-BEQ-TOP 4901 Material: 701050839

Batch Numbers: 3000063714 3000080869

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Product: Maquet Getinge-BEQ-TOP 15704 Circulatory Circuit 3/8" Material: 701050859

Batch Numbers: 3000047911 3000054555 3000062794 3000071204 3000072306 3000076555

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Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 82703
Status: Resolved
Manufacturer: Maquet Cardiovascular, LLC
Manufactured In: United States
Agency Last Updated: March 27, 2020

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.

Find an Attorney

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.