Maquet recalls two ECC packs due to potential sterility issues during sterilization. The closed stopcock design may prevent humidity and ethylene oxide gas from flowing, risking contamination.
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 two specific ECC packs because their design might cause sterility problems during sterilization. This could lead to contaminated medical equipment if not properly sterilized.
The closed stopcock configuration prevents humidity and ethylene oxide gas from flowing through the fluid path during sterilization. This can compromise the sterility assurance level, potentially leading to contaminated equipment.
Healthcare professionals using these packs for extracorporeal circulation may be affected. Patients receiving treatment with these packs face the lowest risk of contamination.
Check for batch numbers: 3000058184, 3000067382, 3000069380, 3000071967, 3000074322 for model 701065765R01 or 3000077734 for model 701065765R02.
Look for batch numbers 3000058184, 3000067382, 3000069380, 3000071967, 3000074322 for model 701065765R01 or 3000077734 for model 701065765R02.
The closed stopcock design may prevent humidity and ethylene oxide gas from flowing during sterilization, risking contamination of the equipment.
Check the batch numbers listed in the recall notice to see if your pack is affected.
The recall notice does not specify a remedy, so no action is required beyond checking the 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-1663-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1663-2019 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.
