Maquet recalls BEQ-TOP 32200 ECC Packs with batch 3000077744 due to potential sterility issues during sterilization. Affected units may not meet sterility standards if humidity/ethylene oxide gas cannot flow properly.
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 32200 ECC Packs that could fail sterility checks during sterilization. This means the medical device might not be safe for use after cleaning, risking infection in surgeries.
During sterilization, the closed stopcock design may block humidity and ethylene oxide gas from flowing into the fluid path. This prevents the device from meeting sterility standards, potentially allowing harmful bacteria to survive.
Healthcare professionals using the BEQ-TOP 32200 ECC Packs with batch number 3000077744 are most at risk. Patients undergoing surgery with these packs could face infection if the device fails sterility checks.
Check for batch number 3000077744 on the BEQ-TOP 32200 ECC Pack. The product is sold by Maquet Cardiovascular, LLC.
Look for batch number 3000077744 on the BEQ-TOP 32200 ECC Pack.
The recall states that the product may not meet sterility standards during sterilization, so it is not safe for use without the remedy.
Check for batch number 3000077744 on the BEQ-TOP 32200 ECC Pack.
The recall does not specify a remedy, so contact Maquet Cardiovascular, LLC 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-1643-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1643-2019 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.
