Maquet recalls specific ECC 3/8" packs due to potential sterility issues during sterilization. The closed stopcock design may prevent proper humidity and gas flow, risking contamination. Affected units have listed batch numbers.
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 3/8" packs because their stopcock design might not allow proper humidity and gas flow during sterilization. This could lead to contamination and compromise sterility assurance. Affected units have specific batch numbers listed in the recall.
The closed stopcock configuration may block humidity and ethylene oxide gas from flowing into the fluid path during sterilization. This prevents the system from achieving proper sterility assurance levels, potentially leading to contamination.
Healthcare professionals using these packs for extracorporeal circulation systems. Patients and staff are at risk if the packs become contaminated due to improper sterilization.
Check for the batch numbers: 3000048232, 3000049610, 3000056811, 3000063949, 3000067795, 3000071203, 3000071783. The product is a Maquet Getinge-BEQ-TOP 33700 ECC 3/8" pack with material code 701053845.
Verify your unit's batch number against the listed numbers: 3000048232, 3000049610, 3000056811, 3000063949, 3000067795, 3000071203, 3000071783.
The closed stopcock design may prevent proper humidity and ethylene oxide gas flow during sterilization, risking contamination and compromising sterility assurance.
Batch numbers: 3000048232, 3000049610, 3000056811, 3000063949, 3000067795, 3000071203, 3000071783.
The recall record does not specify a remedy.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1529-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1529-2019 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.
