Maquet recalls specific Getinge-BEQ-TOP 38300 Adult CPS QID tubing sets due to potential sterility issues during sterilization. Affected units have batch numbers 3000047632, 3000052206, 3000055637, 3000060482, 3000067466.
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 Getinge-BEQ-TOP 38300 Adult CPS QID tubing sets because they may not maintain sterility during sterilization. This could lead to infections if the equipment is used without proper sterility.
During sterilization, the 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 ECC treatments with the affected units could face infection risks.
Check for the model 'Getinge-BEQ-TOP 38300 ADULT CPS QID' and batch numbers 3000047632, 3000052206, 3000055637, 3000060482, or 3000067466.
Identify the batch number on the tubing set to confirm if it is affected.
The tubing set may not maintain sterility during sterilization due to its closed stopcock design, which can trap humidity and ethylene oxide gas.
Batch numbers 3000047632, 3000052206, 3000055637, 3000060482, and 3000067466 are affected.
The recall does not require immediate discontinuation; however, affected units should be checked for sterility risks before use.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1542-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1542-2019 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.
