Maquet recalls specific Getinge-BEQ-TOP 30901 Custom CPB Packs due to potential sterility issues during sterilization. Affected units have batch numbers 3000044877, 3000045089, or 3000045951. Contact for remedy.
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
Maquet is recalling certain Custom CPB Packs for use in extracorporeal circulation because improper sterilization could compromise sterility. This affects medical devices used in heart surgeries. If you have the recalled batch numbers, stop using the pack immediately.
During sterilization, the closed stopcock design may trap humidity and ethylene oxide gas, preventing proper sterility assurance. This could lead to contamination of the medical device after use.
Healthcare professionals using the Getinge-BEQ-TOP 30901 Custom CPB Packs for heart surgery procedures. Patients undergoing heart surgery are at risk if the pack is used without proper sterility.
Check the batch numbers on the pack: 3000044877, 3000045089, or 3000045951. The product is labeled as Maquet Getinge-BEQ-TOP 30901 Custom CPB Pack with material code 701063071.
Look for batch numbers 3000044877, 3000045089, or 3000045951 on the pack.
The affected batch numbers are 3000044877, 3000045089, and 3000045951.
Patients undergoing heart surgery could be at risk if the pack is used without proper sterility, but the recall is for healthcare providers to ensure safe use.
The recall record does not specify a remedy.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1552-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1552-2019 from Maquet. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
