Maquet recalls BEQ-TOP 32100 Adult Custom Packs due to potential sterility issues during sterilization. Affected units have specific batch numbers and material codes.
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 its BEQ-TOP 32100 Adult Custom Packs because improper sterilization could compromise sterility. This affects medical devices used in extracorporeal circulation procedures.
During sterilization, the closed stopcock configuration may trap humidity and ethylene oxide gas, preventing proper sterility assurance. This could lead to contamination of the device if not properly sterilized.
Healthcare professionals using the BEQ-TOP 32100 Adult Custom Packs for extracorporeal circulation procedures. Patients receiving such treatments are at risk if the device fails to maintain sterility.
Check for batch numbers 3000077084 or 3000084911 and material code 701054438R01 on the packaging. The product is sold under the Maquet Getinge brand.
Identify batch numbers 3000077084 or 3000084911 and material code 701054438R01 on the packaging.
The closed stopcock configuration during sterilization may prevent proper humidity and ethylene oxide gas flow, risking sterility assurance.
Check for batch numbers 3000077084 or 3000084911 and material code 701054438R01. If affected, contact Maquet for further instructions.
The recall addresses potential sterility issues, not direct injury risks. The hazard level is low risk.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1649-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1649-2019 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.
