Maquet recalls specific ECC packs due to potential sterility issues during sterilization. The closed stopcock design may prevent humidity and ethylene oxide gas flow, risking contamination.
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 Getinge-BEQ-TOP 5502 ECC packs because their stopcock design might not allow proper humidity and gas flow during sterilization, which could lead to contamination. This affects medical devices used in extracorporeal circulation.
The closed stopcock configuration in the pack may block humidity and ethylene oxide gas from flowing into the fluid path during sterilization. This could compromise the sterility assurance level, potentially leading to contamination of the device.
Healthcare professionals using the Getinge-BEQ-TOP 5502 ECC packs for extracorporeal circulation. Patients receiving these devices are at risk if the packs become contaminated during sterilization.
Check for the product name 'Getinge-BEQ-TOP 5502 ECC Pack' with material code 701051791. Affected units have batch numbers 3000043651, 3000047320, 3000062721, 3000064716, or 3000072309.
Identify the material code and batch numbers listed in the recall notice to confirm if your device is affected.
The affected batch numbers are 3000043651, 3000047320, 3000062721, 3000064716, and 3000072309.
The closed stopcock design may prevent proper humidity and ethylene oxide gas flow during sterilization, risking contamination of the device.
The recall notice does not specify a remedy; affected units should be checked and potentially replaced.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1517-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1517-2019 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.
