Maquet recalls Getinge-BO-T 41301 BUMC ECC Pack material 701065209 due to potential sterility issues during sterilization. Affected units have specific batch numbers.
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 a specific blood circulation pack because its design might not ensure proper sterility during sterilization. This could lead to infections if the device is used without being fully sterile.
The tubing's closed stopcock design may trap humidity and ethylene oxide gas during sterilization. This can compromise the sterility of the device, potentially causing infections if used without proper sterility.
Healthcare professionals using this blood circulation pack in medical settings. Patients receiving treatments with this device are at risk if the sterilization process fails.
Check for the model number Getinge-BO-T 41301 BUMC ECC PACK and material code 701065209. Affected units have batch numbers 3000049454, 3000054311, 3000054314, or 3000055640.
Identify the model number and material code to confirm if your device is affected.
The product may not be fully sterile after sterilization due to the tubing design, so it should not be used without proper sterility checks.
Batch numbers 3000049454, 3000054311, 3000054314, and 3000055640 are affected.
The recall indicates the sterility cannot be assured during sterilization, so healthcare professionals should verify sterility before use.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1568-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1568-2019 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.
