Maquet recalls pediatric Mercy Adaptation material due to potential sterility issues during sterilization. Affected units have specific batch numbers. Consumers should contact Maquet for details.
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 pediatric Mercy Adaptation materials because improper sterilization could compromise sterility. This affects medical devices used in extracorporeal circulation.
During sterilization, the closed stopcock configuration may prevent humidity and ethylene oxide gas from flowing into the fluid path. This could lead to unassured sterility in the stopcock ports, potentially causing infections.
Healthcare professionals using pediatric extracorporeal circulation devices. Patients receiving such treatments are at risk if the device is not properly sterilized.
Check for batch numbers 3000079888 or 3000081748 on the product label. The product is a pediatric Mercy Adaptation kit for extracorporeal circulation.
Reach out to Maquet Cardiovascular for specific instructions on handling the affected product.
Batch numbers 3000079888 and 3000081748.
The closed stopcock configuration may prevent proper humidity and gas flow during sterilization, risking unassured sterility.
Look for batch numbers 3000079888 or 3000081748 on the product label.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1628-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1628-2019 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.
