Maquet recalls specific 1/4" ECC Packs with RF32 material that may not maintain sterility during sterilization due to tubing design. Affected units have batch numbers 3000044427, 3000054806, 3000059172, 3000069470.
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 1/4" ECC Packs with RF32 material because their design may prevent proper sterilization, risking contamination. This affects medical devices used in extracorporeal circulation procedures.
During sterilization, the closed stopcock design may block humidity and ethylene oxide gas from flowing into the fluid path. This could compromise the sterility assurance level, potentially leading to infections.
Healthcare professionals using the Maquet Getinge-BEQ-T 8025 1/4" ECC Pack with RF32 material for extracorporeal circulation procedures. Patients receiving such treatments are at risk if the device fails to maintain sterility.
Check for batch numbers 3000044427, 3000054806, 3000059172, or 3000069470 on the product label. The product is a 1/4" ECC Pack with RF32 material from Maquet Getinge-BEQ-T 8025.
Look for batch numbers 3000044427, 3000054806, 3000059172, or 3000069470 on the product label.
The recalled device is the Maquet Getinge-BEQ-T 8025 1/4" ECC Pack with RF32 material.
The closed stopcock design may prevent proper humidity and ethylene oxide gas flow during sterilization, risking contamination.
Check for batch numbers 3000044427, 3000054806, 3000059172, or 3000069470 on the product label.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1537-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1537-2019 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.
