Maquet recalls Getinge-T 5220 UAB Hospital Accessory (batch 3000054667, 3000067797, 3000073970, 3000076941) due to potential sterility issues during sterilization. Affected hospitals should check their equipment.
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 specific hospital tubing sets because they might not stay sterile after sterilization. This could lead to infections if used improperly.
During sterilization, the tubing's closed stopcock design may block humidity and ethylene oxide gas from flowing into the fluid path. This could compromise the sterility assurance level, increasing infection risk.
Hospitals using the Getinge-T 5220 UAB tubing sets with batch numbers 3000054667, 3000067797, 3000073970, or 3000076941 are most at risk. These units are used in hospitals for extracorporeal circulation.
Check for batch numbers 3000054667, 3000067797, 3000073970, or 3000076941 on the Getinge-T 5220 UAB hospital tubing sets. These were sold to hospitals for extracorporeal circulation use.
Look for batch numbers 3000054667, 3000067797, 3000073970, or 3000076941 on the tubing sets.
The tubing's closed stopcock design may prevent proper humidity and ethylene oxide gas flow during sterilization, risking infection.
The recall record does not specify a remedy, so hospitals should contact Maquet for guidance.
The recall indicates a potential sterility risk during sterilization, so it should not be used until the issue is resolved.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1618-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1618-2019 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.
