Maquet recalls Getinge-BEQ-TOP 21506 ECC packs with batch numbers 3000046810, 3000054159, 3000066889, 3000074123 due to potential sterility issues during sterilization.
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 ECC 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 design may prevent humidity and ethylene oxide gas from flowing into the fluid path during sterilization. This could compromise the sterility assurance level, increasing infection risk.
Healthcare professionals using these packs for extracorporeal circulation systems are most at risk. Patients receiving such treatments could be affected if the packs are not properly sterilized.
Check for batch numbers 3000046810, 3000054159, 3000066889, or 3000074123 on the packaging. The product is labeled as Maquet Getinge-BEQ-TOP 21506 ECC Pack.
Look for batch numbers 3000046810, 3000054159, 3000066889, or 3000074123 on the packaging.
The closed stopcock design may prevent humidity and ethylene oxide gas from flowing into the fluid path during sterilization, potentially compromising sterility assurance.
Batch numbers 3000046810, 3000054159, 3000066889, and 3000074123.
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-1555-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1555-2019 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.
