Maquet recalls specific Rotaflow support packs due to potential sterility issues during sterilization. Affected units have batch numbers 3000074503, 3000078944, or 3000081155. Contact for replacement.
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 Rotaflow support packs 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 configuration may block humidity and ethylene oxide gas from flowing into the fluid path. This can compromise the sterility assurance level, potentially causing infections.
Healthcare professionals using the Rotaflow support packs for extracorporeal circulation. Patients using these packs during medical procedures are at risk of infection.
Check for batch numbers 3000074503, 3000078944, or 3000081155 on the Rotaflow support packs. The product is sold under the brand Maquet.
Look for batch numbers 3000074503, 3000078944, or 3000081155 on the Rotaflow support pack.
The recalled product is the Maquet Getinge-BEQ-T 48003 Rotaflow ONLY Support Pack with material code 709000490.
Check the batch numbers on the support pack: 3000074503, 3000078944, or 3000081155.
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-1625-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1625-2019 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.
