Maquet recalls Getinge-T 41303 AV Manifolds for ECC use due to potential sterility issues during sterilization. Affected units have specific batch numbers. 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 its Getinge-T 41303 AV Manifolds for extracorporeal circulation use because improper sterilization could compromise sterility. This affects medical devices used in critical care settings.
During sterilization, the closed stopcock configuration may block humidity and ethylene oxide gas from reaching the fluid path. This could lead to unverified sterility in the stopcock ports, potentially causing infections.
Healthcare professionals using these manifolds for extracorporeal circulation (ECC) procedures are most at risk. The recall targets specific batch numbers sold to hospitals and clinics.
Check for batch numbers: 3000041542, 3000046483, 3000049065, 3000055328, 3000057682, 3000060483, 3000063712. The product is labeled as Maquet Getinge-T 41303 AV MANIFOLD FOR ECC PA.
Look for batch numbers 3000041542, 3000046483, 3000049065, 3000055328, 3000057682, 3000060483, or 3000063712 on the device.
The closed stopcock configuration may prevent humidity and ethylene oxide gas from flowing into the fluid path during sterilization, risking unverified sterility in the stopcock ports.
Check the batch numbers listed. If your device has one of these batch numbers, contact Maquet for instructions.
The recall addresses potential sterility issues, not direct injury risks. The hazard is low risk as it relates to infection prevention rather than immediate harm.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1579-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1579-2019 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.
