Maquet recalls specific ECC PACK units due to potential sterility issues during sterilization. Affected units have batch numbers 3000045173, 3000046396, 3000046746. 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 ECC PACK units because improper sterilization may compromise sterility. This could lead to infections if the medical device is used without proper sterility assurance.
During sterilization, the closed stopcock design may trap humidity and ethylene oxide gas, preventing proper sterility assurance. This could lead to contamination if the device is used without adequate sterility.
Healthcare professionals using the Maquet Getinge-BEQ-T 39700 ECC PACK for extracorporeal circulation. Patients receiving treatments with these units are at risk if sterility is compromised.
Check for batch numbers 3000045173, 3000046396, or 3000046746 on the Maquet Getinge-BEQ-T 39700 ECC PACK units. These units were sold with the specified material code 701062473.
Look for batch numbers 3000045173, 3000046396, or 3000046746 on the product.
Batch numbers 3000045173, 3000046396, and 3000046746 are affected.
Check for batch numbers 3000045173, 3000046396, or 3000046746 on the Maquet Getinge-BEQ-T 39700 ECC PACK units.
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-1549-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1549-2019 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.
