Maquet recalls BEQ-TOP 24100 Small Patient ECC Packs with batch numbers 3000041467-3000083165 due to potential sterility issues during sterilization. Affected units may not meet sterility standards after processing.
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 specific BEQ-TOP 24100 Small Patient ECC Packs because their sterilization process might not ensure sterility. This could lead to infections if the equipment is used without proper sterility.
During sterilization, the closed stopcock configuration may block humidity and ethylene oxide gas from flowing into the fluid path. This can compromise the sterility assurance level, potentially leading to infections if the equipment is used without proper sterility.
Healthcare professionals using the BEQ-TOP 24100 Small Patient ECC Packs for extracorporeal circulation. Patients receiving such treatments are at risk if the equipment isn't properly sterilized.
Check for batch numbers: 3000041467, 3000050581, 3000055641, 3000060358, 3000067467, 3000073974, or 3000083165. The product is a BEQ-TOP 24100 Small Patient ECC Pack from Maquet Getinge.
Look for batch numbers 3000041467, 3000050581, 3000055641, 3000060358, 3000067467, 3000073974, or 3000083165 on the product.
Batch numbers 3000041467, 3000050581, 3000055641, 3000060358, 3000067467, 3000073974, and 3000083165.
The closed stopcock configuration may prevent humidity and ethylene oxide gas from flowing into the fluid path during sterilization, potentially compromising sterility assurance.
The recall record does not mention a remedy or fix for this issue.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1635-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1635-2019 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.
