Maquet recalls BEQ-TOP 41201 ECC 3/8 Pump Packs with batch numbers 3000080724 and 3000084928 due to potential sterility issues during sterilization. Affected units may not meet sterility standards if improperly configured.
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 BEQ-TOP 41201 ECC 3/8 Pump Packs because their tubing configuration can fail to ensure proper sterility during sterilization. This risk 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 pump is used without proper sterility.
Healthcare professionals using the BEQ-TOP 41201 ECC 3/8 Pump Packs for extracorporeal circulation. Patients receiving treatments with these pumps are at risk if the equipment is not properly sterilized.
Check for batch numbers 3000080724 or 3000084928 on the pump pack. The product is labeled as BEQ-TOP 41201 ECC 3/8 Pump Pack with material code 701064867R01.
Look for batch numbers 3000080724 or 3000084928 on the pump pack.
The recalled model is BEQ-TOP 41201 ECC 3/8 Pump Pack with material code 701064867R01.
The closed stopcock configuration may prevent proper humidity and ethylene oxide gas flow during sterilization, risking inadequate sterility assurance.
Check for batch numbers 3000080724 or 3000084928 on the pump pack label.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1661-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1661-2019 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.
