Maquet recalls specific circulatory circuit tubing for potential sterility issues during sterilization. Affected units have batch numbers 3000047911, 3000054555, 3000062794, 3000071204, 3000072306, 3000076555. Contact for replacement.
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 circulatory circuit tubing that may not maintain sterility during sterilization. This could lead to infections if used in medical procedures. Affected units have specific batch numbers listed in the recall.
During sterilization, the tubing's closed stopcock configuration may trap humidity and ethylene oxide gas, preventing proper sterility assurance. This could lead to contamination if the tubing is used in medical procedures without being fully sterilized.
Healthcare professionals using the circulatory circuit tubing for extracorporeal circulation procedures are most at risk. Patients receiving such treatments could be affected if the tubing is not properly sterilized.
Check for batch numbers 3000047911, 3000054555, 3000062794, 3000071204, 3000072306, or 3000076555 on the tubing packaging. The product is labeled as Maquet Getinge-BEQ-TOP 15704 Circulatory Circuit 3/8" with material code 701050859.
Look for batch numbers 3000047911, 3000054555, 3000062794, 3000071204, 3000072306, or 3000076555 on the tubing packaging.
Batch numbers 3000047911, 3000054555, 3000062794, 3000071204, 3000072306, and 3000076555 are affected.
The tubing's closed stopcock configuration may prevent proper humidity and ethylene oxide gas flow during sterilization, risking sterility assurance.
The recall does not specify a remedy, so contact Maquet directly for guidance on next steps.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1511-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1511-2019 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.
