Maquet recalls Getinge-BEQ-T 53400 Adaption Packs with batch numbers 3000047192, 3000049558, 3000067521 due to potential sterility issues when sterilizing. Affected units may not meet sterility standards after 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 adaption packs for extracorporeal circulation use because they may not maintain sterility during sterilization. This could lead to infections if the packs are used without proper sterility.
During sterilization, the closed stopcock configuration in these adaption packs may prevent humidity and ethylene oxide gas from flowing into the fluid path. This can compromise the sterility assurance level, potentially leading to infections if the packs are used without proper sterility.
Healthcare professionals using the Getinge-BEQ-T 53400 Adaption Packs for extracorporeal circulation procedures are most at risk. The recall affects specific batch numbers of the adaption packs.
Check for batch numbers 3000047192, 3000049558, or 3000067521 on the adaption packs. The product is labeled as Maquet Getinge-BEQ-T 53400 Adaption Pack with material code 709000213.
Look for batch numbers 3000047192, 3000049558, or 3000067521 on the adaption pack.
The adaption pack may not maintain sterility during sterilization due to a closed stopcock configuration that prevents humidity and ethylene oxide gas from flowing into the fluid path.
Batch numbers 3000047192, 3000049558, and 3000067521.
Check for batch numbers 3000047192, 3000049558, or 3000067521 on the Maquet Getinge-BEQ-T 53400 Adaption Pack with material code 709000213.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1607-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1607-2019 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.
