Maquet recalls specific custom tubing sets for extracorporeal circulation due to potential sterility issues during sterilization. Affected units have batch numbers 3000050481, 3000052617, 3000054413, 3000054961, 3000055976. Contact for remedy.
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 custom tubing sets for extracorporeal circulation 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 the tubing for extracorporeal circulation procedures. Patients receiving such treatments are at risk if the tubing is not properly sterilized.
Check for batch numbers 3000050481, 3000052617, 3000054413, 3000054961, or 3000055976 on the packaging. The product is a custom pack labeled 'Maquet Getinge-BEQ-TOP 31203 NEO' with material code 701065510.
Look for batch numbers 3000050481, 3000052617, 3000054413, 3000054961, or 3000055976 on the packaging.
The tubing may not maintain sterility during sterilization due to its closed stopcock design, which can trap humidity and ethylene oxide gas.
Batch numbers 3000050481, 3000052617, 3000054413, 3000054961, and 3000055976.
The recall does not specify a stop-use action; check batch numbers to determine if your unit is affected.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1570-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1570-2019 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.
