Maquet recalls specific adult ECC packs due to potential sterility issues during sterilization. The closed stopcock design may prevent proper humidity and gas flow, risking contamination. Affected units have batch numbers 3000045728, 3000051160, or 3000058050.
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 adult ECC packs because their design may cause sterility issues during sterilization. This could lead to contaminated medical devices if not properly sterilized, posing a risk to patient safety.
The closed stopcock and non-vented cap configuration might block humidity and ethylene oxide gas from flowing into the fluid path during sterilization. This could compromise the sterility assurance level, potentially leading to contaminated medical devices.
Healthcare professionals using the Maquet Getinge-BO-TOP 28903 Adult ECC Pack with batch numbers 3000045728, 3000051160, or 3000058050 are most at risk. Patients receiving these devices could face potential contamination.
Check for batch numbers 3000045728, 3000051160, or 3000058050 on the Maquet Getinge-BO-TOP 28903 Adult ECC Pack. The product is sold as a medical device for extracorporeal circulation.
Look for batch numbers 3000045728, 3000051160, or 3000058050 on the product label.
The affected batch numbers are 3000045728, 3000051160, and 3000058050.
The closed stopcock design may prevent proper humidity and gas flow during sterilization, risking contamination of the medical device.
The recall record does not specify a remedy or fix for this issue.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1601-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1601-2019 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.
