Maquet recalls BO-TOP 28903 Adult ECC Packs with batch 3000069722 due to potential sterility issues during sterilization. Affected units may not meet sterility standards after processing.
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 adult ECC pack model because its design might not maintain sterility during sterilization. This could lead to infections if the medical device isn't properly sterilized.
The closed stopcock and non-vented cap design may trap humidity and ethylene oxide gas during sterilization. This can compromise the sterility assurance level, potentially causing infections in medical procedures.
Healthcare professionals using the BO-TOP 28903 Adult ECC Pack with batch number 3000069722 are affected. Patients receiving this device during surgery are at risk of infection if the pack isn't properly sterilized.
Check for the batch number 3000069722 on the BO-TOP 28903 Adult ECC Pack. The product was sold by Maquet Getinge with this specific model and batch.
Look for batch number 3000069722 on the BO-TOP 28903 Adult ECC Pack.
The product may not meet sterility standards after sterilization, so it should not be used until the recall is addressed.
Check the batch number on the product. If it matches 3000069722, contact Maquet for instructions.
The recall record does not specify a replacement process or remedy.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1676-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1676-2019 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.
