Maquet recalls specific ECC packs for potential sterility issues during sterilization due to tubing design. Affected units have batch numbers listed; 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 ECC packs that may not maintain sterility during sterilization. This could lead to infections if used improperly.
During sterilization, the tubing design may block humidity and ethylene oxide gas from flowing into the fluid path. This could compromise the sterility assurance level, potentially causing infections.
Healthcare professionals using these packs for extracorporeal circulation systems. Patients receiving such treatments are at risk if the packs are not properly sterilized.
Check for batch numbers: 3000043158, 3000045091, 3000046739, 3000050831, 3000062044, or 3000065548. The product name is Maquet Getinge-BEQ-TOP 49103 ECC Pack 0 with no bladder material.
Look for batch numbers 3000043158, 3000045091, 3000046739, 3000050831, 3000062044, or 3000065548 on the product.
The product is Maquet Getinge-BEQ-TOP 49103 ECC Pack 0 with no bladder material.
Check for batch numbers: 3000043158, 3000045091, 3000046739, 3000050831, 3000062044, or 3000065548.
The recall does not specify a remedy; contact Maquet for further instructions.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1598-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1598-2019 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.
