Maquet recalls specific ECC packs due to potential sterility issues during sterilization. The closed stopcock design may prevent proper humidity and gas flow, risking contamination. Affected units have batch numbers listed in the recall notice.
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 packs because their design during sterilization might not ensure sterility. This could lead to contamination if the packs are used in medical procedures. Affected units have specific batch numbers listed in the recall.
The closed stopcock configuration in these packs may block humidity and ethylene oxide gas from flowing properly during sterilization. This can cause the sterility assurance level to fail, potentially leading to contamination of the medical equipment.
Medical professionals using the Maquet ECC packs for extracorporeal circulation procedures are most at risk. Patients receiving these packs during surgery may be affected if the sterility is compromised.
Check the batch numbers on the pack: 3000056807, 3000058047, 3000061214, 3000064945, 3000068116, 3000071379, 3000071832, 3000080848, or 3000081908. The product is labeled as Maquet Getinge- BEQ-T 39700 ECC Pack.
Look for batch numbers 3000056807, 3000058047, 3000061214, 3000064945, 3000068116, 3000071379, 3000071832, 3000080848, or 3000081908 on the pack.
The closed stopcock design may prevent proper humidity and ethylene oxide gas flow during sterilization, risking contamination.
Check the batch numbers listed: 3000056807, 3000058047, 3000061214, 3000064945, 3000068116, 3000071379, 3000071832, 3000080848, or 3000081908.
The recall does not specify a stop-use action, so you can continue using them but should check batch numbers.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1657-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1657-2019 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.
