Maquet recalls specific tubing sets for extracorporeal circulation due to potential sterility issues during sterilization. Affected units have batch numbers 3000061513, 3000071803, 3000075279, 3000077546. 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 tubing sets used in extracorporeal circulation because they may not maintain sterility during sterilization. This could lead to infections if the equipment is used without proper sterility.
During sterilization, the tubing's closed stopcock design may block humidity and ethylene oxide gas from reaching the fluid path. This could compromise the sterility assurance level, increasing infection risk.
Healthcare professionals using the Maquet Getinge-BEQ-T 9409 Lurie Chlds Large 3/8 tubing sets with batch numbers 3000061513, 3000071803, 3000075279, or 3000077546 are most at risk.
Check for batch numbers 3000061513, 3000071803, 3000075279, or 3000077546 on the tubing sets. The product name is Maquet Getinge-BEQ-T 9409 Lurie Chlds Large 3/8.
Look for batch numbers 3000061513, 3000071803, 3000075279, or 3000077546 on the tubing sets.
The recalled model is Maquet Getinge-BEQ-T 9409 Lurie Chlds Large 3/8.
Batch numbers 3000061513, 3000071803, 3000075279, and 3000077546 are affected.
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-1619-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1619-2019 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.
