Maquet recalls specific custom tubing sets for extracorporeal circulation due to potential sterility issues during sterilization. Affected units have batch numbers starting with 3000056132.
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 custom tubing sets for extracorporeal circulation because they may not maintain sterility during sterilization. This could lead to infections if the tubing is used without proper sterility.
During sterilization, the tubing's closed stopcock design may trap humidity and ethylene oxide gas, preventing proper sterility assurance. This could lead to contamination if the tubing is used without adequate sterility.
Healthcare professionals using these tubing sets for extracorporeal circulation systems. Patients receiving treatments through these systems are at risk if the tubing is not properly sterilized.
Check for batch numbers starting with 3000056132 on the Maquet Getinge-BEQ-TOP 31204 Custom Pack Pedi tubing sets. The product includes material code 701065512.
Look for batch numbers starting with 3000056132 on the tubing set.
The tubing set may not maintain sterility during sterilization due to its closed stopcock design, which can trap humidity and ethylene oxide gas.
Batch numbers starting with 3000056132.
The recall does not provide a fix; affected units should be checked and replaced if necessary.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1571-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1571-2019 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.
