Maquet recalls specific Getinge-BEQ-TOP 15705 tubing sets due to potential sterility issues during sterilization. The closed stopcock design may prevent proper humidity and gas flow, risking contamination.
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 15705 tubing sets because their design may cause sterility issues during sterilization. This could lead to contaminated medical devices if not properly sterilized.
The tubing's closed stopcock and non-vented cap design may block humidity and ethylene oxide gas from flowing into the fluid path during sterilization. This can compromise the sterility assurance level, potentially leading to contamination of medical devices.
Healthcare professionals using these tubing sets for extracorporeal circulation (ECC) systems are most at risk. Patients receiving ECC treatments could be affected if the tubing is contaminated.
Check for the model number Getinge-BEQ-TOP 15705 and batch numbers listed: 3000044566, 3000046394, 3000049202, 3000054550, 3000058043, 3000060239, 3000066276, 3000069368, 3000071833, 3000074339, 3000080701, 3000081598.
Verify the model number and batch numbers listed in the recall notice to confirm if your tubing set is affected.
The closed stopcock and non-vented cap design may prevent proper humidity and ethylene oxide gas flow during sterilization, risking contamination of medical devices.
Batch numbers: 3000044566, 3000046394, 3000049202, 3000054550, 3000058043, 3000060239, 3000066276, 3000069368, 3000071833, 3000074339, 3000080701, 3000081598.
The recall notice does not specify a remedy, so affected users should check with the manufacturer for further instructions.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1514-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1514-2019 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.
