Maquet recalls specific 4" pressure pigtails for extracorporeal circulation due to potential sterility issues during sterilization. Affected units have batch numbers listed in the recall notice.
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 4" pressure pigtails used in extracorporeal circulation systems because they may not maintain sterility during sterilization. This could lead to infections if the equipment is not properly sterilized.
During sterilization, the closed stopcock design may trap humidity and ethylene oxide gas, preventing proper sterility assurance. This could lead to contamination if the tubing is not sterilized correctly.
Healthcare professionals using extracorporeal circulation systems are most likely affected. The risk is primarily for medical devices used in specific surgical procedures.
Check for the model 'Maquet Getinge-T 8028 PRESSURE PIGTAIL 4"' with batch numbers 3000054751, 3000055509, 3000061510, 3000066891, 3000075388, 3000080435, 3000080699, or 3000081533.
Verify if your pressure pigtails have any of the listed batch numbers: 3000054751, 3000055509, 3000061510, 3000066891, 3000075388, 3000080435, 3000080699, 3000081533.
The closed stopcock design may prevent proper humidity and ethylene oxide gas flow during sterilization, risking contamination.
Batch numbers 3000054751, 3000055509, 3000061510, 3000066891, 3000075388, 3000080435, 3000080699, and 3000081533.
No immediate action is required; check batch numbers to determine if your item is affected.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1544-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1544-2019 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.
