Maquet recalls specific batch numbers of Getinge-BEQ-TOP 24500 Adult ECC tubing sets due to potential sterility issues during sterilization. Affected units may not meet sterility standards if improperly configured.
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 batches of Getinge-BEQ-TOP 24500 Adult ECC tubing sets because their design might fail to ensure sterility during sterilization. This could lead to infections if the tubing isn't properly sterilized.
The tubing's closed stopcock configuration may block humidity and ethylene oxide gas from flowing into the fluid path during sterilization. This can compromise the sterility assurance level, potentially allowing contaminants to remain in the tubing.
Healthcare professionals using these tubing sets for extracorporeal circulation (ECC) in medical procedures are most at risk. Patients receiving treatments with the affected units could face infection risks.
Check for the model 'Getinge-BEQ-TOP 24500 ADULT ECC' with batch numbers 3000041126, 3000053053, 3000054958, 3000055326, 3000064943, 3000066814, or 3000071782.
Identify the batch number on the tubing set to confirm if it is affected.
The tubing's closed stopcock configuration may prevent proper humidity and ethylene oxide gas flow during sterilization, risking contamination.
Batch numbers 3000041126, 3000053053, 3000054958, 3000055326, 3000064943, 3000066814, and 3000071782.
If the tubing isn't properly sterilized, it could lead to infections in patients undergoing 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-1508-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1508-2019 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.
