Maquet recalls Getinge-BEQ-T 27904 3/8 transport packs with batch numbers 3000057680-3000080799 due to potential sterility issues during sterilization. Affected units may not meet sterility standards.
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 Getinge-BEQ-T 27904 3/8 transport packs because they might not stay sterile after sterilization. This could lead to infections during medical procedures.
During sterilization, the closed stopcock design may block humidity and ethylene oxide gas from reaching the fluid path. This could compromise the sterility assurance level, increasing infection risks during medical procedures.
Healthcare professionals using these transport packs for extracorporeal circulation (ECC) procedures are most at risk. Patients receiving ECC treatments could be affected if the packs are not properly sterile.
Check for batch numbers: 3000057680, 3000066687, 3000075125, 3000075898, or 3000080799. The product is a 3/8 transport pack with material code 701064804.
Verify the batch number on the transport pack to see if it matches the listed numbers: 3000057680, 3000066687, 3000075125, 3000075898, or 3000080799.
The closed stopcock design may prevent humidity and ethylene oxide gas from reaching the fluid path during sterilization, potentially compromising sterility assurance.
Check the batch number on the transport pack. If it matches the listed numbers, stop using it and contact Maquet for instructions.
Yes, if the transport pack is not properly sterile, it could lead to infections during extracorporeal circulation procedures.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1560-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1560-2019 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.
