Maquet recalls specific adult 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 3000042145 or 3000056049.
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 adult ECC packs because their design may cause sterility issues during sterilization. This could lead to contaminated medical equipment if not properly sterilized, posing a risk to patient safety.
The closed stopcock design in these packs may prevent humidity and ethylene oxide gas from flowing properly during sterilization. This could compromise the sterility assurance level, increasing the risk of contamination in medical equipment.
Healthcare providers using the Maquet Getinge-BEQ-TOP 24101 Adult ECC Pack with batch numbers 3000042145 or 3000056049 are most at risk. Patients receiving treatments with these packs could face potential contamination.
Check for batch numbers 3000042145 or 3000056049 on the Maquet Getinge-BEQ-TOP 24101 Adult ECC Pack. The product is sold under the brand Maquet.
Look for batch numbers 3000042145 or 3000056049 on the product label.
Batch numbers 3000042145 and 3000056049 are affected.
The recall record does not specify a remedy.
The closed stopcock design may prevent proper humidity and gas flow during sterilization, potentially compromising 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-1636-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1636-2019 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.
