Maquet recalls specific bladder materials for extracorporeal circulation devices due to potential sterility issues during sterilization. Affected units include batch numbers 3000059445, 3000062029, 3000062476, and 3000080867.
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 bladder materials for extracorporeal circulation devices because they may not maintain sterility during sterilization. This could lead to infections if the equipment is used without proper sterility.
During sterilization, the closed stopcock configuration may prevent humidity and ethylene oxide gas from flowing into the fluid path. This could compromise the sterility assurance level, potentially leading to infections if the device is used without proper sterility.
Healthcare professionals using Maquet Getinge-BEQ-T 25502 1/4 Better Bladder materials with batch numbers 3000059445, 3000062029, 3000062476, or 3000080867 are most at risk.
Check for batch numbers 3000059445, 3000062029, 3000062476, or 3000080867 on the Maquet Getinge-BEQ-T 25502 1/4 Better Bladder materials.
Verify the batch number on the bladder material to see if it matches 3000059445, 3000062029, 3000062476, or 3000080867.
Batch numbers 3000059445, 3000062029, 3000062476, and 3000080867 are affected.
The closed stopcock configuration may prevent humidity and ethylene oxide gas from flowing into the fluid path during sterilization, potentially compromising sterility assurance.
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-1621-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1621-2019 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.
