Maquet recalls specific tubing packs for extracorporeal circulation due to potential sterility issues during sterilization. Affected units have batch numbers listed in the recall notice.
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 tubing packs used in extracorporeal circulation systems because they may not maintain sterility during sterilization. This could lead to infections if the tubing is used without proper sterility assurance.
During sterilization, the tubing's closed stopcock design may trap humidity and ethylene oxide gas, preventing proper sterility assurance. This could result in contaminated tubing that poses infection risks.
Healthcare professionals using extracorporeal circulation systems may be affected. Patients receiving such treatments could be at risk if the tubing is not properly sterilized.
Check for batch numbers: 3000044416, 3000049077, 3000053102, 3000054957, 3000056257, 3000061306, 3000070701, or 3000072685. The product is labeled as Maquet Getinge-BEQ-TOP 5103#CPS Tubing Pack.
Look for batch numbers listed in the recall: 3000044416, 3000049077, 3000053102, 3000054957, 3000056257, 3000061306, 3000070701, or 3000072685.
The tubing pack may not maintain sterility during sterilization due to its closed stopcock design, which can trap humidity and ethylene oxide gas.
Batch numbers 3000044416, 3000049077, 3000053102, 3000054957, 3000056257, 3000061306, 3000070701, and 3000072685 are affected.
The recall does not specify a remedy, so there is no immediate action required beyond checking batch numbers.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1501-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1501-2019 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.
