Maquet recalls specific tubing packs for extracorporeal circulation due to potential sterility issues during sterilization. Affected units have batch numbers 3000077756 or 3000078014. 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 certain extracorporeal circulation tubing packs because they may not maintain sterility during sterilization. This could lead to infections if the tubing is used in medical procedures without proper sterility.
During sterilization, the tubing's closed stopcock design may trap humidity and ethylene oxide gas, preventing proper sterility assurance. This could lead to contamination if the tubing is used in medical procedures without adequate sterility.
Healthcare professionals using the tubing packs for extracorporeal circulation systems are most at risk. Patients using these systems could be affected if the tubing is not properly sterilized.
Check for batch numbers 3000077756 or 3000078014 on the tubing pack. The product is labeled as Maquet Getinge-BEQ-TOP 5103 CPS Tubing Pack.
Look for batch numbers 3000077756 or 3000078014 on the tubing pack.
The affected batch numbers are 3000077756 and 3000078014.
The tubing's design may prevent proper sterility during sterilization, risking contamination in medical procedures.
The recall record does not specify a remedy.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1630-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1630-2019 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.
