Maquet recalls specific ECC packs for potential sterility issues during sterilization. The closed stopcock design may prevent proper humidity and gas flow, risking contamination. Affected units have batch numbers 3000044419, 3000045727, or 3000065141.
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 due to a sterility risk during sterilization. The closed stopcock design may prevent proper humidity and gas flow, potentially leading to contamination. This affects medical devices used in extracorporeal circulation.
The closed stopcock configuration may block humidity and ethylene oxide gas from flowing into the fluid path during sterilization. This could compromise the sterility assurance level, increasing the risk of contamination in medical devices.
Healthcare professionals using the Maquet Getinge-BEQ-TOP 27609 ECC packs for extracorporeal circulation are most at risk. The specific batch numbers listed in the recall are affected units.
Check for the batch numbers 3000044419, 3000045727, or 3000065141 on the Maquet Getinge-BEQ-TOP 27609 ECC packs. The product includes a 1/4" material code 701065504.
Identify if your unit has batch numbers 3000044419, 3000045727, or 3000065141.
The closed stopcock design may prevent proper humidity and gas flow during sterilization, risking contamination of the medical device.
Batch numbers 3000044419, 3000045727, and 3000065141 are affected.
The recall does not specify a stop-use instruction; check batch numbers to determine if your unit is affected.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1569-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1569-2019 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
