Maquet recalls specific custom tubing sets 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 custom tubing sets used in extracorporeal circulation systems because they may not maintain sterility during sterilization. This could lead to infections if the tubing is not properly sterilized.
During sterilization, the closed stopcock configuration in these tubing sets may prevent humidity and ethylene oxide gas from flowing into the fluid path. This could compromise the sterility assurance level, potentially leading to infections.
Healthcare professionals using the Maquet Getinge-BEQ-TOP 9004 1/4 Custom Pk tubing sets for extracorporeal circulation. Patients receiving such treatments are at risk if the tubing is not properly sterilized.
Check for batch numbers: 3000050941, 3000053625, 3000069865, 3000071831, 3000080721, or 3000083489. The product is labeled as Maquet Getinge-BEQ-TOP 9004 1/4 Custom Pk with RF32 & HMOD material.
Look for batch numbers 3000050941, 3000053625, 3000069865, 3000071831, 3000080721, or 3000083489 on the tubing set.
The tubing sets may not maintain sterility during sterilization, potentially leading to infections if not properly sterilized.
Check for batch numbers: 3000050941, 3000053625, 3000069865, 3000071831, 3000080721, or 3000083489.
The recall does not specify a remedy, so contact Maquet directly for guidance.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1650-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1650-2019 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.
