Maquet recalls BEQ-TOP 5210 ECC Set respiratory material due to potential sterility issues during sterilization. Affected units have specific batch numbers. Consumers should contact Maquet for details.
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 5210 ECC Set respiratory material because improper sterilization could compromise sterility. This affects specific batch numbers and requires action to prevent infection risks.
During sterilization, the closed stopcock configuration may block humidity and ethylene oxide gas from reaching the fluid path. This could lead to unverified sterility, increasing infection risks.
Medical professionals using the BEQ-TOP 5210 ECC Set for extracorporeal circulation. Those with specific batch numbers are most at risk.
Check the batch numbers: 3000044876, 3000047906, 3000051750, 3000056130, 3000061303, 3000062457, 3000071820. The product is labeled as BEQ-TOP 5210 ECC Set respiratory material.
Look for batch numbers: 3000044876, 3000047906, 3000051750, 3000056130, 3000061303, 3000062457, 3000071820.
The closed stopcock configuration may prevent humidity and ethylene oxide gas from reaching the fluid path during sterilization, risking unverified sterility.
Batch numbers: 3000044876, 3000047906, 3000051750, 3000056130, 3000061303, 3000062457, 3000071820.
The recall does not specify a stop-use action; check batch numbers and contact Maquet for further instructions.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1654-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1654-2019 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.
