Maquet recalls specific BEQ-TOP 54500 BSW-McLANE 3/8 Quadrox iD tubing sets due to potential sterility issues during sterilization. Affected units have batch numbers starting with 3000077081.
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 BEQ-TOP 54500 BSW-McLANE 3/8 Quadrox iD tubing sets because they may not maintain sterility during sterilization. This could lead to infections if the tubing is used in medical procedures.
During sterilization, the tubing's closed stopcock design may trap humidity and ethylene oxide gas, preventing proper sterility assurance. This could allow contaminants to remain in the tubing, increasing infection risk during medical procedures.
Healthcare professionals using these tubing sets for extracorporeal circulation (ECC) procedures are most at risk. Patients receiving such treatments could face infection if the tubing is not properly sterilized.
Check for batch numbers starting with 3000077081 on the tubing sets. The product is labeled as BEQ-TOP 54500 BSW-McLANE 3/8 Quadrox iD with material code 709000496R01.
Look for batch numbers starting with 3000077081 on the tubing sets.
The tubing set may not maintain sterility during sterilization due to its closed stopcock design, which can trap humidity and ethylene oxide gas.
Check the batch number; if it starts with 3000077081, contact Maquet for further instructions.
The recall addresses infection risk during medical procedures, not direct injury. The hazard does not involve immediate physical harm.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1680-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1680-2019 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.
