CLASS II Device recall · Reported 5 Jun 2019 · FDA Enforcement Report

Maquet Getinge-Beq-top 32100 Adult Custom Pac Material:701054438 recalled

Maquet Cardiovascular is recalling Maquet Getinge-Beq-top 32100 Adult Custom Pac Material:701054438, distributed nationwide in the US. The recall was initiated on 18 Apr 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesBatch Numbers: 3000043291 3000044425 3000046811 3000047912 3000052203 3000053795 3000059174 3000062478 3000066197 3000067469 3000070703 3000074122 3000075896

Quantity recalledN/A

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1533-2019
FDA event ID: 82703
Recalling firm: Maquet Cardiovascular, Wayne, NJ
Classification: Class II
Status: Terminated
Recall initiated: 18 Apr 2019
FDA classified: 30 May 2019
Reported: 5 Jun 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Other Medical Devices

Timeline

18 Apr 2019	Recall initiated by company
30 May 2019	Classified by FDA	+42 days
5 Jun 2019	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for 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

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

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

Where was it sold?

Nationwide

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

100 other products · FDA event 82703

This product is part of a recall event; the main page for the event is Maquet Getinge-Beq-top 5502 ECC Pack Material:701051791R01 recalled.

Reported	Class	Recall	Company	Reason	Where
5 Jun 2019	CLASS II	Maquet Getinge-Beq-top 5502 ECC Pack Material:701051791R01 recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge-Beq-top 21502# Med City Childr Material recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge-Bo-top 15200 OR Pack Hmo & RF Material:701050647R01 recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge-Beq-top 22701 Material recalled by Maquet Cardiovascular	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge-Beq-top 41201 Ecc 3/8 Pump Pac Material recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge- Bo-top 13901 Rapid Response Universal Pk recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge-Beq-t 3502 Lvad 1/4" Material recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge-Beq-t 37305 1/4+3/8 Table Line Material recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge- Material: 701065765R01 Bo-top 36504 Adult recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge-Beq-top 24202 Adult Ecc Material:701054295 recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge- Beq-top 32200 ECC Pack Material: 701053319R01 recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge-Beq-top 5208 Ecc Set Cardiac Material recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge-Beq-top 35503 SGD Pack Material:701068797R01 recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge Bo-top 48400 OR Pack Material: 701064327R01 recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge- Beq-top 28901 Mcv Infant Ecc Material:701056771R01 recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge-Beq-t 48003 Rotaflow Only Support Pack recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge-Beq-t 25501 3/8" Better Bladder Pack recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge-Beq-top 44701 Pediatric Ecc Material recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge-Beq-top 5909 W Qpid Material recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge-Beq-t 8506 Transport Pack Material recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge-Beq-top 33501 1/4" Ecc Pack Material recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge-Beq-top 38900 Ecc Pack Material recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge-Beq-top 8013 Ecc Quadrox iD Pack RF32 recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge- Beq-top 37200 E-Circuit Bioline Heparin recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge-Bo-top 28903 Adult ECC Pack Material recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge-Beq-t 8805 Ecc Pack Material recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge-Beq-top 33704 Ecc 1/4" Pack Material recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge-T 8030 High Flow Pigtail Material recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge-Beq-top 27901 Small Patient CI Material:701052287 recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge-Beq-t 51501 Ochsner ECC Pack Material:709000113 recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge-Beq-t 3502 Lvad 1/4" Material: 701068168R01 recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge- Material: 701067350R01 Beq-top 5208 ECC recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge-Beq-top 9004 1/4 Custom Pk w/RF32 & Hmod recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge-Beq-top 33700 Ecc 3/8" Pack Material recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge-Beq-t 5914 TCH ¿ Inch Change Kit Material recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge-Beq-top 21502 ECC Quadrox iD w/RF 3/8" recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge- Beq-t 9411 Lurie Children's 1/4 Adapt recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge-Beq-top 26402 Ecc Pack Material recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge Beq-top 38300 Adult Cps Qid Material:701055862R01 recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge-Beq-top 3700 Tubing Pack Material recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge-Beq-top 38002 Adult Specialty Material recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge-Beq-top 37302 Quadrox iD Pediatric Pack recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge-Bo-t 6600 Tubing Pack Material:701052324 recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge-Beq-t 4917 Mercy Medical Versa-Pack Material recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge-Beq-top 1601#Quadrox iD - Pack Material:701052285 recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge-Beq-top 37500 Ecc Quadrox ID Material recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge-Beq-top 25001 Montefiore Material recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge- Bo-t 41301 Bumc Ecc Pack Material: -701065209R01 recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge-Beq-top 250011/4 1/4 Less than up Material recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge-Beq-t 51502 Ochsner ECC Ancillary Pack recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge-Beq-top 8075 S-Quadrox iD Plus Pack wRF3 recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge-Beq-t 49002 Rotaflow Support Pack Material recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge-Beq-top 35503 SGD Pack Material recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge-Beq-top 8013 Ecc Quadrox iD Pack RF32 recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge-Beq-top 8208# ECC Pack Material recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge-Beq-top 27609 Ecc Pack 1/4" Material recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge-BO-T 52360 Cardioplegia Pack Material recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge-Bo-top 26300 Custom Pack Material recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge-Beq-top 22600 Ecc Quadrox iD 3/8 recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge- Material :701067370R01 Bo-top 38803 Open recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge Beq-t 3501 Lvad 3/8" Material: 701068008R01 recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge-Beq-top 31203 Custom Pack Neo Material recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge-Beq-t 9410 Lurie Chldns Small 1/4 Material recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge-Beq-top 38302 Infant Cps Qpid Material recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge-Beq-t 4963 Cardioplegia Pack Material recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge-Beq-t 9403 Small Patient Tubing Pack recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge-Beq-top 15704 Circulatory Circuit 3/8" recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge-Beq-top 25500 ECC AV Loop w Qx-iD Material recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge-Beq-top 15705 Material recalled by Maquet Cardiovascular	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge-Beq-t 8069 Pediatric Pack Material recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge-Beq-top 31204 Custom Pack Pedi Material recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge-Beq-t 48002 Bridge Kit Material recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge-Beq-top 7005 Uamc Pediatric Ecc Pack recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge-Beq-t 53400 Adaption Pack Material recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge-Beq-t 16405 Liver TX Infusion Material:701066097 recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge-Beq-top 5103#CPS Tubing Pack Material recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge-Beq-top 31000 Pediatric Ecc Material:701052843 recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge-Beq-t 5908 Tch Hls Ancillary Material recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge-Beq-t 25502 1/4 Better Bladder Material recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge-Beq-top 2202 Neonatal Specialt Material:701062613 recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge-Beq-top 50100 Chosa 1/4" Ecc Pack Material recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge-Beq-top 50903 Custom ECC Pk-Pdtrc 3/8 recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge-Beq-top 32200 Ecc Pack - Material recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge-Beq-t 27904 3/8 Transport Pack Material:701064804 recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge-Beq-top 25500 ECC 3/8 w/QiD Material recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge-Beq-top 37200 Circulatory Circ Material recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge-Beq-t 5915 TCH Change Kit Material recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge-T 5220 UAB Hospital Accessory Material recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge-BO-T 51502 Ochsner ECC Adult Pack Material recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge-Beq-top 25003 3//8 TO 7LPM Material recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge-Beq-top 40700 Huntington Material:701062899 recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge-Beq-top 17207 3/8" ECC Pack Material:701049346R01 recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge-Beq-top 5502 ECC Pack Material recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge-Beq-top 5103 CPS Tubing Pack Material:701048690R01 recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge-Beq-t 4906 Pediaric Cpb Pack Material recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge- Beq-top 5900 TCH 3/8 Quadrox-iD Pack recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge-Beq-t 9405 Large Patient Tbg P Material:701066366 recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge-Beq-top 15800 Tubing Pack Material recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge- Beq-t 39700 ECC Pack Material:701062473R01 recalled	Maquet Cardiovascular	Sterility	Nationwide
5 Jun 2019	CLASS II	Maquet Getinge-Bo-top 14605 Open Heart Withou Material recalled	Maquet Cardiovascular	Sterility	Nationwide

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