Lower risk Medical device recall · FDA · Published April 18, 2019

Maquet Getinge-BEQ-TOP 550: Sterility Risk During Sterilization

Maquet recalls Getinge-BEQ-TOP 5502 ECC packs with batch numbers 3000074733 and 3000081599 due to potential sterility issues after sterilization.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1640-2019Medical device Maquet ›

Lower-risk recall

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

Take action

Contact the company

Recalling firmMaquet Cardiovascular, LLC45 Barbour Pond Dr · Wayne, NJ 07470-2094

✎ GovInfoNow plain-language explainer

Maquet is recalling specific ECC packs because improper sterilization could lead to contamination. This affects medical devices used in extracorporeal circulation. Read more at govinfonow.com/recall/68123-maquet-getinge-beq-top-550-sterility-risk-during-sterilization.

Source Summary by GovInfoNow · govinfonow.com/recall/68123-maquet-getinge-beq-top-550-sterility-risk-during-sterilization · Updated August 20, 2026 · FDA enforcement record: FDA #Z-1640-2019

Cite this page

“Maquet Getinge-BEQ-TOP 550: Sterility Risk During Sterilization.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/68123-maquet-getinge-beq-top-550-sterility-risk-during-sterilization. Based on FDA recall #Z-1640-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1640-2019%22&limit=1).

The FDA announced on April 18, 2019, that Maquet Cardiovascular, LLC is recalling the Maquet Getinge-BEQ-TOP 5502 ECC Pack Material:701051791R01 due to potential sterility assurance failures. The agency classified the recall as Class II.

How to tell if you have it

Brand: Maquet
Product: Maquet Getinge-BEQ-TOP 5502 ECC Pack Material:701051791R01
Batch Numbers: 3000074733, 3000081599

The hazard

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. This prevents the Sterility Assurance Level (SAL) of the stopcock ports from being assured.

Context

GovInfoNow's records show Maquet Cardiovascular, LLC has 25 other recalls on record since January 24, 2019. Other recent recalls include a June 2, 2026 recall of the Maquet Vasoview Hemopro 2 for gamma sterilization issues and an August 15, 2025 recall of the Maquet Heartstring III Proximal Seal System for hemostasis failure risk. Similar recent recalls of comparable products include a June 9, 2026 Zimmer Sterile Tourniquet Hoses recall for sterility breach risk and a July 31, 2026 Maquet Percutaneous Insertion Kit (PIK) L Model 701054427 recall for sterile packaging risk.

How to tell if you have this one

Check for batch numbers 3000074733 or 3000081599 on the Maquet Getinge-BEQ-TOP 5502 ECC packs. The product is sold under the brand Maquet.

Brand
Maquet
Category
Medical device

FDA recall event · 183 products

All 183 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Terminated
Distribution
Nationwide

Recall number	Product, codes & lots
Z-1498-2019	Maquet Getinge-BEQ-TOP 15800 TUBING PACK Material: 3000065087; Batch Numbers: 3000062267, 3000065087
Z-1499-2019	Maquet Getinge-BEQ-TOP 8013 ECC QUADROX iD Pack RF32 Material: 701047962; Batch Numbers: 3000047630 3000050482 3000055980 3000060726 3000066813 3000068491 3000070813 3000074323
Z-1500-2019	Maquet Getinge-BEQ-T 8803#Circ Circuit Small Patient Material: 701048539; Batch Numbers: Batch 3000043059 3000051269 3000067520 3000072508 3000080853
Z-1501-2019	Maquet Getinge-BEQ-TOP 5103#CPS Tubing Pack Material: 701048690; Batch Numbers: 3000044416 3000049077 3000053102 3000054957 3000056257 3000061306 3000070701 3000072685
Z-1502-2019	Maquet Getinge-BEQ-TOP 17207 3/8 ECC PACK Material: 701049346; Batch Numbers: 3000043292 3000047704 3000050576 3000052263 3000060362 3000065492 3000066201 3000071202
Z-1503-2019	Maquet Getinge-BEQ-T-22800 Material: 701049506; Batch Numbers: 3000046489 3000055506
Z-1504-2019	Maquet Getinge-BEQ-TOP 3700 Tubing Pack Material: 701049510; Batch Numbers: 3000069367
Z-1505-2019	Maquet Getinge-BEQ-T 9403 Small Patient Tubing Pack Material: 701049994; Batch Numbers: 3000041414 3000047036 3000050575 3000051657
Z-1506-2019	Maquet Getinge-BEQ-TOP 21502# Med City Childr Material: 701050060; Batch Numbers: 3000049556 3000067468
Z-1507-2019	Maquet Getinge-BEQ-TOP 5900 3/8 Quadrox iD Pack w/BB Material: 701050228; Batch Numbers: 3000048233 3000048397 3000054333 3000058183 3000069469 3000074100
Z-1508-2019	Maquet Getinge-BEQ-TOP 24500 ADULT ECC Material: 701050253; Batch Numbers: 3000041126 3000053053 3000054958 3000055326 3000064943 3000066814 3000071782
Z-1509-2019	Maquet Getinge-BEQ-TOP 22701 Material: 701050790; Batch Numbers: 3000060359 3000060495 3000062725 3000071781
Z-1510-2019	Maquet Getinge-BEQ-TOP 4901 Material: 701050839; Batch Numbers: 3000063714 3000080869
Z-1511-2019	Maquet Getinge-BEQ-TOP 15704 Circulatory Circuit 3/8" Material: 701050859; Batch Numbers: 3000047911 3000054555 3000062794 3000071204 3000072306 3000076555
Z-1512-2019	Maquet Getinge-BO-TOP 20700 SMALL PATIENT 3/8 Material: 701050966; Batch Numbers: 3000063810 3000068490 3000071784 3000076463
Z-1513-2019	Maquet Getinge-BO-TOP 26300 CUSTOM PACK Material: 701050975; Batch Numbers: 3000043848 3000050583 3000050645 3000053626 3000054146
Z-1514-2019	Maquet Getinge-BEQ-TOP 15705 Material: 701051122; Batch Numbers: 3000044566 3000046394 3000049202 3000054550 3000058043 3000060239 3000066276 3000069368 3000071833 3000074339 3000080701 3000081598
Z-1515-2019	Maquet Getinge-BEQ-TOP 22702 ECC W/HMOD 30000 Material: 701051179; Batch Numbers: 3000045170 3000058051 3000062455 3000065508
Z-1516-2019	Maquet Getinge-BEQ-TOP 7005 UAMC Pediatric ECC Pack Material: 701051515; Batch Numbers: 3000041127 3000049458 3000061103 3000065550 3000071378 3000075338 3000081601
Z-1517-2019	Maquet Getinge-BEQ-TOP 5502 ECC Pack Material: 701051791; Batch Numbers: 3000043651 3000047320 3000062721 3000064716 3000072309
Z-1518-2019	Maquet Getinge-BEQ-TOP 1601#QUADROX iD - Pack Material:701052285; Batch Numbers: 3000048235 3000056129 3000059730 3000065496 3000070700 3000073428
Z-1519-2019	Maquet Getinge-BEQ-TOP 27901 SMALL PATIENT CI Material:701052287; Batch Numbers: Batch 3000065552 3000070971 3000074623 3000076634 3000080868
Z-1520-2019	Maquet Getinge-BO-T 6600 TUBING PACK Material:701052324; Batch Numbers: 3000073972
Z-1521-2019	Maquet Getinge-BEQ-TOP 25500 ECC 3/8 w/QiD Material: 701052461; Batch Numbers: 3000065224 3000074124
Z-1522-2019	Maquet Getinge-BO-TOP 30300 Material:701052623; Batch Numbers: 3000043293 3000045086 3000050830 3000058048
Z-1523-2019	Maquet Getinge-BEQ-TOP 31000 PEDIATRIC ECC Material:701052843; Batch Numbers: 3000058044 3000062463 3000075430
Z-1524-2019	Maquet Getinge-BEQ-TOP 32200 ECC PACK - Material: 701053319; Batch Numbers: 3000043054 3000049462 3000058326 3000062722 3000069369 3000073168
Z-1525-2019	Maquet Getinge-BEQ-T 8805 ECC PACK Material: 701053361; Batch Numbers: 3000071966 3000074121 3000075280 3000077082
Z-1526-2019	Maquet Getinge-BO-TOP 20705 SMALL PATIENT 1/4 Material: 701053486; Batch Numbers: 3000048716 3000054549 3000061302 3000067224 3000070815 3000072509 3000076464
Z-1527-2019	Maquet Getinge-BEQ-TOP 33500 3/8" ECC PACK Material: 701053752; Batch Numbers: 3000056255
Z-1528-2019	Maquet Getinge-BEQ-TOP 33501 1/4" ECC PACK Material: 701053754; Batch Numbers: 3000054158
Z-1529-2019	Maquet Getinge-BEQ-TOP 33700 ECC 3/8" PACK Material: 701053845; Batch Numbers: 3000048232 3000049610 3000056811 3000063949 3000067795 3000071203 3000071783
Z-1530-2019	Maquet Getinge-BEQ-TOP 25001 MONTEFIORE Material: 701053906; Batch Numbers: 3000054551 3000065085
Z-1531-2019	Maquet Getinge-BEQ-TOP 33704 ECC 1/4" PACK Material: 701054150; Batch Numbers: 3000049611 3000058052 3000062459 3000066196
Z-1532-2019	Maquet Getinge-BEQ-TOP 24202 ADULT ECC Material:701054295; Batch Numbers: 3000057379 3000063707 3000066885 3000071785 3000071806 3000073164
Z-1533-2019	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
Z-1534-2019	Maquet Getinge-BEQ-TOP 21503 ECC 1/4" AV LOOP Material:701054776; Batch Numbers: 3000043295 3000047248 3000047254 3000055638 3000062271 3000065551 3000069074 3000075386
Z-1535-2019	Maquet Getinge-BO-TOP 13901 RAPID RESPONSE Material:701054874; Batch Numbers: 3000044426 3000049067 3000053796 3000054622 3000067221 3000067796 3000072147 3000074175
Z-1536-2019	Maquet Getinge-T 22706 SAMPLE MANIFOLD Material:701054912; Batch Numbers: 3000055636
Z-1537-2019	Maquet Getinge-BEQ-T 8025 1/4" ECC Pack with RF32 Material:701055142; Batch Numbers: 3000044427 3000054806 3000059172 3000069470
Z-1538-2019	Maquet Getinge-BO-TOP 30901 CUSTOM CPB PACK Material: 701055372; Batch Numbers: 3000061506
Z-1539-2019	Maquet Getinge-BEQ-TOP 37200 CIRCULATORY CIRC Material: 701055388; Batch Numbers: 3000044291 3000046812 3000048395 3000051270 3000054144 3000055979 3000058735 3000061304 3000063708 3000066691 3000070702 3000072307 3000075122
Z-1540-2019	Maquet Getinge-BEQ-TOP 37500 ECC QUADROX ID Material: 701055601; Batch Numbers: 3000048238 3000061109 3000069075
Z-1541-2019	Maquet Getinge-BEQ-TOP 38002 ADULT SPECIALTY Material:; Batch Numbers: 3000055504
Z-1542-2019	Maquet Getinge-BEQ-TOP 38300 ADULT CPS QID Material: 701055862; Batch Numbers: 3000047632 3000052206 3000055637 3000060482 3000067466
Z-1543-2019	Maquet Getinge-BEQ-TOP 38302 INFANT CPS QPID Material: 701055866; Batch Numbers: 3000045221 3000049201 3000054750 3000062046 3000065497 3000067793 3000069723 3000072247 3000075339 3000080720 3000084636
Z-1544-2019	Maquet Getinge-T 8028 PRESSURE PIGTAIL 4" Material: 701055993; Batch Numbers: 3000054751 3000055509 3000061510 3000066891 3000075388 3000080435 3000080699 3000081533
Z-1545-2019	Maquet Getinge-T 8029 PRESSURE PIGTAIL 6" Material: 701055995; Batch Numbers: 3000058045 3000069467 3000072507 3000080702
Z-1546-2019	Maquet Getinge-BEQ-T 4906 PEDIARIC CPB PACK Material: 701056041; Batch Numbers: 3000041540
Z-1547-2019	Maquet Getinge-BEQ-TOP 38900 ECC PACK Material: 701056368; Batch Numbers: 3000041396 3000044053 3000047317 3000050887 3000058131 3000060487 3000060723 3000062458 3000064724 3000071815 3000071817
Z-1548-2019	Maquet Getinge-BEQ-TOP 26402 ECC PACK Material: 701062310; Batch Numbers: 3000043296 3000046809 3000047251 3000050480 3000054805 3000060727 3000066887
Z-1549-2019	Maquet Getinge-BEQ-T 39700 ECC PACK Material:701062473; Batch Numbers: 3000045173 3000046396 3000046746
Z-1550-2019	Maquet Getinge-BEQ-TOP 2202 NEONATAL SPECIALT Material:701062613; Batch Numbers: 3000041407 3000069806
Z-1551-2019	Maquet Getinge-BEQ-TOP 40700 HUNTINGTON Material:701062899; Batch Numbers: 3000057630 3000083783
Z-1552-2019	Maquet Getinge-BEQ-TOP 30901 CUSTOM CPB PACK Material:701063071; Batch Numbers: 3000044877 3000045089 3000045951
Z-1553-2019	Maquet Getinge-BEQ-TOP 41200 ECC 1/4 PUMP PAC Material: 701063149; Batch Numbers: 3000064725
Z-1554-2019	Maquet Getinge-BEQ-TOP 25003 3/8X3/8 TO 7LPM Material: 701063255; Batch Numbers: 3000041007 3000044052 3000045730 3000047318 3000054334 3000054615 3000063091
Z-1555-2019	Maquet Getinge-BEQ-TOP 21506 ECC PACK Material:701064505; Batch Numbers: 3000046810 3000054159 3000066889 3000074123
Z-1556-2019	Maquet Getinge-BEQ-T 5211 LARGE ECC SET Material:701064560; Batch Numbers: Batch 3000041128 3000045731 3000050577 3000052947 3000054617 3000054955 3000057631 3000071818
Z-1557-2019	Maquet Getinge-BEQ-T 5908 TCH HLS ANCILLARY Material: 701064590; Batch Numbers: 3000071399
Z-1558-2019	Maquet Getinge-BEQ-T 30601 CMC ACCESSORY KIT Material: 701064701; Batch Numbers: 3000054160 3000057639 3000058046
Z-1559-2019	Maquet Getinge-BEQ-TOP 24105 ECC PACK Material:701064757; Batch Numbers: 3000051271 3000057632 3000062460 3000066202 3000069076 3000073425 3000076761 3000080703
Z-1560-2019	Maquet Getinge-BEQ-T 27904 3/8 TRANSPORT PACK Material:701064804; Batch Numbers: 3000057680 3000066687 3000075125 3000075898 3000080799
Z-1561-2019	Maquet Getinge-BEQ-TOP 44701 PEDIATRIC ECC Material: 701064825; Batch Numbers: 3000071198
Z-1562-2019	Maquet Getinge-BEQ-T 44200 MAYO PULMONARY P Material: 701064831; Batch Numbers: 3000066688 3000080800
Z-1563-2019	Maquet Getinge-BO-T 44201 MAYO PULMONARY PACK Material: 701064834; Batch Numbers: 3000041415 3000044885 3000077738
Z-1564-2019	Maquet Getinge-BEQ-TOP 41201 ECC 3/8 PUMP PAC Material: 701064867; Batch Numbers: 3000045174 3000049559 3000057376 3000063289 3000069864 3000074097
Z-1565-2019	Maquet Getinge-BEQ-T 8069 Pediatric Pack Material: 701064965; Batch Numbers: 3000046123 3000059176
Z-1566-2019	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
Z-1567-2019	Maquet Getinge-BEQ-TOP 37302 Quadrox iD Pediatric Pack Material: 701065190; Batch Numbers: 3000069382 3000074502
Z-1568-2019	Maquet Getinge-BO-T 41301 BUMC ECC PACK Material: 701065209; Batch Numbers: 3000049454 3000054311 3000054314 3000055640
Z-1569-2019	Maquet Getinge-BEQ-TOP 27609 ECC PACK 1/4" Material: 701065504; Batch Numbers: 3000044419 3000045727 3000065141
Z-1570-2019	Maquet Getinge-BEQ-TOP 31203 CUSTOM PACK NEO Material: 701065510; Batch Numbers: 3000050481 3000052617 3000054413 3000054961 3000055976
Z-1571-2019	Maquet Getinge-BEQ-TOP 31204 CUSTOM PACK PEDI Material: 701065512; Batch Numbers: 3000056132
Z-1572-2019	Maquet Getinge-BO-T 46200 3/16" x 1/4" Neonate Pack Material: 701065620; Batch Numbers: 3000043297 3000045729 3000046485 3000049608 3000052615 3000054322 3000056259 3000062050
Z-1573-2019	Maquet Getinge-BO-TOP 36504 ADULT ECC PACK Material: 701065765; Batch Numbers: 3000043680 3000046039 3000049205 3000052613 3000055536 3000062791
Z-1574-2019	Maquet Getinge-BEQ-TOP 30907 ECC PUMP PACK Material: 701065770; Batch Numbers: 3000041328 3000041619
Z-1575-2019	Maquet Getinge-BEQ-T 46500 PRIME PACK Material:701065823; Batch Numbers: 3000043849 3000046392
Z-1576-2019	Maquet Getinge-BEQ-T 16405 LIVER TX INFUSION Material:701066097; Batch Numbers: 3000055324 3000061509
Z-1577-2019	Maquet Getinge-BO-T 41302 PRIMING LINES BUMC Material:701066291; Batch Numbers: 3000062472 3000071380
Z-1578-2019	Maquet Getinge-BEQ-T 9405 LARGE PATIENT TBG P Material:701066366; Batch Numbers: 3000044415 3000046393 3000046736
Z-1579-2019	Maquet Getinge-T 41303 AV MANIFOLD FOR ECC PA Material:701066551; Batch Numbers: 3000041542 3000046483 3000049065 3000055328 3000057682 3000060483 3000063712
Z-1580-2019	Maquet Getinge-BEQ-TOP 47800 STRINGFELLOW PED Material:701066583; Batch Numbers: 3000046122 3000062040
Z-1581-2019	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
Z-1582-2019	Maquet Getinge-BEQ-T 8068 1/4" WITH BRIDGE Material: 701066883; Batch Numbers: 3000041327 3000042148 3000042819 3000046732 3000054315 3000055642 3000062038 3000066689
Z-1583-2019	Maquet Getinge-BEQ-T 4963 CARDIOPLEGIA PACK Material: 701067203; Batch Numbers: 3000053530 3000058323
Z-1584-2019	Maquet Getinge-BEQ-T 49002 ROTAFLOW SUPPORT PACK Material: 701067280; Batch Numbers: 3000044421
Z-1585-2019	Maquet Getinge-BEQ-TOP 5208 ECC SET CARDIAC Material: 701067350; Batch Numbers: 3000044413 3000049064 3000050885 3000054157 3000058832 3000062461 3000065084
Z-1586-2019	Maquet Getinge-BO-TOP 14605 OPEN HEART WITHOU Material: 701067372; Batch Numbers: 3000047035 3000051157 3000056254 3000059729 3000062036 3000063395
Z-1587-2019	Maquet Getinge-BEQ-T 37305 1/4+3/8 TABLE LINE Material: 701067577; Batch Numbers: 3000066690 3000072826 3000080852
Z-1588-2019	Maquet Getinge-BO-TOP 35503 SGD PACK Material: 701067668; Batch Numbers: 3000056047 3000058250 3000066199
Z-1589-2019	Maquet Getinge-BEQ-TOP 50100 CHOSA 1/4" ECC PACK Material: 701067837; Batch Numbers: 3000041469
Z-1590-2019	Maquet Getinge-BEQ-T 3501 LVAD/ 3/8" Material: 701068008; Batch Numbers: 3000042629 3000057758
Z-1591-2019	Maquet Getinge-BEQ-T 3502 LVAD 1/4" Material: 701068168; Batch Numbers: 3000042630 3000053054 3000054960 3000058830
Z-1592-2019	Maquet Getinge-BEQ-TOP 8207 1/4" ECC PACK Material: 701068395; Batch Numbers: 3000044423
Z-1593-2019	Maquet Getinge-BEQ-TOP 35503 SGD Pack Material: 701068797; Batch Numbers: 3000048720 3000058736 3000063950 3000070973 3000072680 3000075283
Z-1594-2019	Maquet Getinge-BEQ-TOP 8208#3/8 inch ECC Pack Material: 701068798; Batch Numbers: 3000042989 3000058142
Z-1595-2019	Maquet Getinge-BO-T 2303 Small Adult Cardiac Surgery Material:709000004; Batch Numbers: 3000045083 3000046399
Z-1596-2019	Maquet Getinge-BO-T 2302 Pediatric Cardiac Surgery Pack Material: 709000006; Batch Numbers: 3000059175
Z-1597-2019	Maquet Getinge-BEQ-T 30914 ECC Pump Pack 1/4" Material: 709000011; Batch Numbers: 3000064952
Z-1598-2019	Maquet Getinge-BEQ-TOP 49103 ECC Pack 0 No Bladder Material: 709000058; Batch Numbers: 3000043158 3000045091 3000046739 3000050831 3000062044 3000065548
Z-1599-2019	Maquet Getinge-BEQ-T 28906 1/4" with Bridge Ancillary P Material: 709000072; Batch Numbers: 3000062737 3000068119
Z-1600-2019	Maquet Getinge-BEQ-TOP 50903 Custom ECC Pack-Pedriatric Material: 709000078; Batch Numbers: 3000047631 3000054421 3000063290 3000071804 3000073166 3000075337
Z-1601-2019	Maquet Getinge-BO-TOP 28903 Adult ECC Pack Material: 709000093; Batch Numbers: 3000045728 3000051160 3000058050
Z-1602-2019	Maquet Getinge-BEQ-T 51501 Ochsner ECC Pack Material:709000113; Batch Numbers: 3000060038
Z-1603-2019	Maquet Getinge-BEQ-T 51502 Ochsner ECC Ancillary Pack Material:709000115; Batch Numbers: 3000043613 3000076067
Z-1604-2019	Maquet Getinge-BO-T 52360 Cardioplegia Pack Material: 709000127; Batch Numbers: 3000053531 3000060033 3000067120
Z-1605-2019	Maquet Getinge-BO-T 46201 Small Pediatric Cardiac Surge Material: 709000133; Batch Numbers: 3000044424 3000046488 3000049459 3000055093 3000060357
Z-1606-2019	Maquet Getinge-BEQ-T 8506 Transport Pack Material: 709000146; Batch Numbers: 3000075713
Z-1607-2019	Maquet Getinge-BEQ-T 53400 Adaption Pack Material: 709000213; Batch Numbers: 3000047192 3000049558 3000067521
Z-1608-2019	Maquet Getinge-BEQ-T 52301 ¿ Sash & Accessory Pack Material: 709000266; Batch Numbers: 3000044290 3000046395
Z-1609-2019	Maquet Getinge-BEQ-T 5915 TCH 3/8 Inch Change Kit Material: 709000280; Batch Numbers: 3000071199 3000081153
Z-1610-2019	Maquet Getinge-BEQ-T 5914 TCH ¿ Inch Change Kit Material: 709000334; Batch Numbers: 3000071200 3000081154 3000084780
Z-1611-2019	Maquet Getinge-T 8030 4 in High Flow Pigtail Material: 709000366; Batch Numbers: 3000065493
Z-1612-2019	Maquet Getinge-BEQ-T 4917 Mercy Medical Versa-Pack Material: 709000368; Batch Numbers: 3000043162
Z-1613-2019	Maquet Getinge-BEQ-T 25501 3/8" Better Bladder Pack Material: 709000370; Batch Numbers: 3000048718 3000052045 3000060037 3000074174
Z-1614-2019	Maquet Getinge-BO-T 51502 Ochsner ECC Adult Pack Material: 709000385; Batch Numbers: 3000048398 3000075385 3000075472
Z-1615-2019	Maquet Getinge-BEQ-T 36507 Accessory Pk Mercy Material: 709000390; Batch Numbers: 3000048719 3000062269 3000074321 3000077543
Z-1616-2019	Maquet Getinge-BEQ-T 27602 709000417 Adult Custom Pack Material: 709000417; Batch Numbers: 3000061104
Z-1617-2019	Maquet Getinge-BEQ-T 57000 Rotaflow Pack Material: 709000424; Batch Numbers: 3000065091
Z-1618-2019	Maquet Getinge-T 5220 UAB Hospital Accessory Material: 709000426; Batch Numbers: 3000054667 3000067797 3000073970 3000076941
Z-1619-2019	Maquet Getinge-BEQ-T 9409 Lurie Chlds Large 3/8 Material: 709000428; Batch Numbers: 3000061513 3000071803 3000075279 3000077546
Z-1620-2019	Maquet Getinge-BEQ-T 9410 Lurie Chldns Small 1/4 Material: 709000430; Batch Numbers: 3000060035 3000065494 3000067883 3000071809 3000074480 3000075340 3000077550
Z-1621-2019	Maquet Getinge-BEQ-T 25502 1/4 Better Bladder Material: 709000434; Batch Numbers: 3000059445 3000062029 3000062476 3000080867
Z-1622-2019	Maquet Getinge-BEQ-T 48002 Bridge Kit Material: 709000444; Batch Numbers: 3000058085
Z-1623-2019	Maquet Getinge-BEQ-TOP 8075 S-Quadrox iD Plus Pack wRF3 Material: 709000460; Batch Numbers: 3000081747
Z-1624-2019	Maquet Getinge-BEQ-TOP 25503 TMC ¿ with BB & QiD Pedi Material:709000473; Batch Numbers: 3000074399
Z-1625-2019	Maquet Getinge-BEQ-T 48003 Rotaflow ONLY Support Pack Material:709000490; Batch Numbers: 3000074503 3000078944 3000081155
Z-1626-2019	Maquet Getinge-BEQ-TOP 31603 CHKD 3/8" ECC Material: 709000516; Batch Numbers: 3000083879
Z-1627-2019	Maquet Getinge-BEQ-TOP 31604 CHKD 1/4" ECC Material: 709000518; Batch Numbers: 3000083880
Z-1628-2019	Maquet Getinge-BEQ-T 4932 Mercy Adaptation Pk Pediatric Material:709000520; Batch Numbers: 3000079888 3000081748
Z-1629-2019	Maquet Getinge-BEQ-TOP 8013 ECC QUADROX iD Pack RF32 Material:701047962R01; Batch Numbers: 3000078425
Z-1630-2019	Maquet Getinge-BEQ-TOP 5103 CPS Tubing Pack Material:701048690R01; Batch Numbers: 3000077756 3000078014
Z-1631-2019	Maquet Getinge-BEQ-TOP 17207 3/8" ECC Pack Material:701049346R01; Batch Numbers: 3000079611
Z-1632-2019	Maquet Getinge-BEQ-TOP 22600 ECC QUADROX ID 3 Material:701049440R01; Batch Numbers: 3000053103 3000066198 3000071830 3000073677
Z-1633-2019	Maquet Getinge-BEQ-TOP 22600 ECC QUADROX iD 3/8 Material:701049440R02; Batch Numbers: 3000076147
Z-1634-2019	Maquet Getinge-BEQ-TOP 21502 ECC Quadrox iD w/RF 3/8" Material:701050060R01; Batch Numbers: 3000079889
Z-1635-2019	Maquet Getinge- BEQ-TOP 24100 Small Patient ECC Pack Material:701050175R02; Batch Numbers: 3000041467 3000050581 3000055641 3000060358 3000067467 3000073974 3000083165
Z-1636-2019	Maquet Getinge-BEQ-TOP 24101 Adult ECC Pack Material:701050177R01; Batch Numbers: 3000042145 3000056049
Z-1637-2019	Maquet Getinge- BEQ-TOP 5900 TCH 3/8 Quadrox-iD Pack Material:701050228R01; Batch Numbers: 3000077553 3000084779
Z-1638-2019	Maquet Getinge-BO-TOP 15200 OR PACK HMO & RF Material:701050647R01; Batch Numbers: 3000045166 3000050578 3000054620
Z-1639-2019	Maquet Getinge-BEQ-TOP 15704 Circulatory Circuit 3/8" Material:701050859R01; Batch Numbers: 3000077742
Z-1640-2019	Maquet Getinge-BEQ-TOP 5502 ECC Pack Material:701051791R01; Batch Numbers: 3000074733 3000081599
Z-1641-2019	Maquet Getinge-BEQ-TOP 28601 NEONATE ECC QPiD Material: 701051935R01; Batch Numbers: 3000046120 3000062048 3000068120
Z-1642-2019	Maquet Getinge-BEQ-TOP 25500 ECC 3/8 in AV Loop w Qx-iD Material: 701052461R01; Batch Numbers: 3000079891
Z-1643-2019	Maquet Getinge- BEQ-TOP 32200 ECC Pack Material: 701053319R01; Batch Numbers: 3000077744
Z-1644-2019	Maquet Getinge-BO-TOP 20705 SMALL PATIENT 1/4 Material: 701053486R01; Batch Numbers: 3000080434 3000081004
Z-1645-2019	Maquet Getinge-BEQ-TOP 250011/4 1/4 Less than 20 kg up Material: 701053906R01; Batch Numbers: 3000068802 3000071398 3000074190 3000076543
Z-1646-2019	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
Z-1647-2019	Maquet Getinge-BEQ-TOP 24202 ADULT ECC Material: 701054295R01; Batch Numbers: 3000080713
Z-1648-2019	Maquet Getinge- BEQ-TOP 27700 Quadrox iD Pack Material: 701054389R02; Batch Numbers: 3000049066 3000053533
Z-1649-2019	Maquet Getinge- BEQ-TOP 32100 Adult Custom Pack Material:701054438R01; Batch Numbers: 3000077084 3000084911
Z-1650-2019	Maquet Getinge-BEQ-TOP 9004 1/4 Custom Pk w/RF32 & HMOD Material: 701054451R01; Batch Numbers: 3000050941 3000053625 3000069865 3000071831 3000080721 3000083489
Z-1651-2019	Maquet Getinge- BO-TOP 13901 Rapid Response Universal Pk Material: 701054874R01; Batch Numbers: 3000077890 3000079608
Z-1652-2019	Maquet Getinge- BEQ-TOP 37200 E-Circuit Bioline Heparin Material: 701055388R01; Batch Numbers: 3000076762 3000077899 3000078013 3000084649
Z-1653-2019	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
Z-1654-2019	Maquet Getinge- BEQ-TOP 5210 ECC Set - Respiratory Material: 701055604R01; Batch Numbers: 3000044876 3000047906 3000051750 3000056130 3000061303 3000062457 3000071820
Z-1655-2019	Maquet Getinge BEQ-TOP 38300 ADULT CPS QID Material:701055862R01; Batch Numbers: 3000074735 3000080798
Z-1656-2019	Maquet Getinge- BEQ-TOP 28901 MCV INFANT ECC Material:701056771R01; Batch Numbers: 3000046112 3000051162 3000056133 3000062045 3000071402 3000074895 3000075715 3000078940
Z-1657-2019	Maquet Getinge- BEQ-T 39700 ECC Pack Material:701062473R01; Batch Numbers: 3000056807 3000058047 3000061214 3000064945 3000068116 3000071379 3000071832 3000080848 3000081908
Z-1658-2019	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
Z-1659-2019	Maquet Getinge BO-TOP 48400 OR PACK Material: 701064327R01; Batch Numbers: 3000045085 3000047033 3000051653 3000056258 3000062266
Z-1660-2019	Maquet Getinge- BEQ-T 5211 ECC Large Children's Hospital Material: 701064560R01; Batch Numbers: 3000068115 3000081002 3000083490
Z-1661-2019	Maquet Getinge- BEQ-TOP 41201 ECC 3/8 Pump Pack Wake For Material: 701064867R01; Batch Numbers: 3000080724 3000084928
Z-1662-2019	Maquet Getinge- BO-T 41301 BUMC ECC PACK Material: -701065209R01; Batch Numbers: 3000060743 3000066277 3000069078 3000073171 3000074176 3000076468 3000080999 3000081905 3000085277
Z-1663-2019	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
Z-1664-2019	Maquet Getinge- BEQ-TOP 46700 ADULT ECC PACK Material:701065833R01; Batch Numbers: 3000076856 3000077891
Z-1665-2019	Maquet Getinge-BEQ-TOP 49101 Childrens Large ECC Pack Material: 701067069R01; Batch Numbers: 3000059724
Z-1666-2019	Maquet Getinge- BEQ-TOP 39202 NICU ECC PACK Material: 701067313R01; Batch Numbers: 3000043846 3000047255 3000052044 3000061508 3000074098 3000078928 3000079607
Z-1667-2019	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
Z-1668-2019	Maquet Getinge BEQ-TOP 40010 OPEN HEART PACK Material: -701067364R02; Batch Numbers: 3000058180 3000062474
Z-1669-2019	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
Z-1670-2019	Maquet Getinge BEQ-T 3501 LVAD 3/8" Material: 701068008R01; Batch Numbers: 3000074094
Z-1671-2019	Maquet Getinge-BEQ-T 3502 LVAD 1/4" Material: 701068168R01; Batch Numbers: 3000074095 3000082174
Z-1672-2019	Maquet Getinge-BEQ-TOP 35503 SGD Pack Material:701068797R01; Batch Numbers: 3000079609
Z-1673-2019	Maquet Getinge- BO-T 2303 3/8" x 3/8" Adult Pack Material: 709000004R01; Batch Numbers: 3000058327
Z-1674-2019	Maquet Getinge-BEQ-TOP 50900 Custom ECC Pack-Neonatal ¿ Material: 709000069R02; Batch Numbers: 3000051158 3000061507 3000067518 3000069468
Z-1675-2019	Maquet Getinge-BEQ-TOP 50903 Custom ECC Pk-Pdtrc 3/8 - Material: 709000078R01; Batch Numbers: 3000078943
Z-1676-2019	Maquet Getinge BO-TOP 28903 Adult ECC Pack Material: -709000093R01; Batch Numbers: 3000069722
Z-1677-2019	Maquet Getinge- BEQ-T 53500 Evanston Rotaflow Pack Material:709000215R01; Batch Numbers: 3000045168 3000046484 3000062270 3000064946 3000084054
Z-1678-2019	Maquet Getinge-BEQ-T 52301 ¿ Sash & Accessory Pack Material:-709000266R01; Batch Numbers: 3000053797 3000057760 3000063952 3000067187 3000069726 3000072683 3000075716
Z-1679-2019	Maquet Getinge- BEQ-T 9411 Lurie Children's 1/4 ADAPT Material:709000485R01; Batch Numbers: 3000076765
Z-1680-2019	Maquet Getinge- BEQ-TOP 54500 BSW-McLANE 3/8 Quadrox iD Material:709000496R01; Batch Numbers: 3000077081

Based on the official FDA remedy

What to do — step by step

Check Batch Numbers
Look for batch numbers 3000074733 or 3000081599 on the product label.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 6.3 years after the firm started it.

Apr 18, 2019Firm started the recall
May 30, 2019FDA classified it Class II
Jun 5, 2019Published in FDA’s Enforcement Report
Jul 28, 2025FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

Similar recalls

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Keep exploring

More Maquet recalls

Link to this recall

<a href="https://govinfonow.com/recall/68123-maquet-getinge-beq-top-550-sterility-risk-during-sterilization">Maquet Getinge-BEQ-TOP 550: Sterility Risk During Sterilization (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1640-2019 (April 18, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1640-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.