Maquet recalls specific BEQ-T 5211 ECC tubing sets for children's hospitals due to potential sterility issues during sterilization. Affected units have batch numbers 3000068115, 3000081002, or 3000083490.
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 ECC tubing sets for children's hospitals because they may not maintain sterility during sterilization. This could lead to infections if the tubing is used without proper sterility.
During sterilization, the tubing's closed stopcock design may block humidity and ethylene oxide gas from flowing into the fluid path. This could compromise the sterility assurance level, potentially leading to infections if the tubing is used without proper sterility.
Healthcare facilities using the specific BEQ-T 5211 ECC tubing sets with batch numbers 3000068115, 3000081002, or 3000083490 are most at risk. These units are intended for large children's hospital use.
Check for batch numbers 3000068115, 3000081002, or 3000083490 on the tubing's packaging or label. The product is labeled as BEQ-T 5211 ECC Large Children's Hospital Material.
Look for batch numbers 3000068115, 3000081002, or 3000083490 on the tubing packaging or label.
Batch numbers 3000068115, 3000081002, and 3000083490 are affected.
The recall record does not specify a remedy.
The tubing may not maintain sterility during sterilization, potentially leading to infections if used without proper sterility assurance.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1660-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1660-2019 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.
