Maquet recalls specific ECC 1/4" packs due to potential sterility issues during sterilization. Affected units have batch numbers 3000049611, 3000058052, 3000062459, 3000066196. Contact for remedy.
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 1/4" packs because their design may fail to ensure sterility during sterilization. This could lead to infections if the equipment is used without proper sterility.
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, potentially causing infections if the equipment is used without proper sterility.
Healthcare professionals using the Maquet Getinge-BEQ-TOP 33704 ECC 1/4" packs for extracorporeal circulation. Those handling the specific batch numbers listed are most at risk.
Check for the batch numbers: 3000049611, 3000058052, 3000062459, or 3000066196 on the product label. The product is a Maquet Getinge-BEQ-TOP 33704 ECC 1/4" pack with material code 701054150.
Look for batch numbers 3000049611, 3000058052, 3000062459, or 3000066196 on the product label.
Batch numbers 3000049611, 3000058052, 3000062459, and 3000066196.
The closed stopcock design may prevent humidity and ethylene oxide gas from flowing into the fluid path during sterilization, risking compromised sterility assurance.
The recall record does not specify a remedy, so contact Maquet directly for guidance.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1531-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1531-2019 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.
