Maquet recalls specific ECC pumps due to potential sterility issues when sterilized. The closed stopcock design may prevent proper humidity and gas flow, risking contamination. Affected units have batch number 3000064725.
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 ECC pumps because their design may cause sterility problems during sterilization. This could lead to contaminated medical devices if not properly sterilized, posing a risk to patient safety.
The pump's closed stopcock design may prevent humidity and ethylene oxide gas from flowing properly during sterilization. This can compromise the sterility assurance level, potentially leading to contaminated medical devices.
Healthcare professionals using the Maquet Getinge-BEQ-TOP 41200 ECC 1/4 PUMP PAC pumps with batch number 3000064725 are most at risk. Patients receiving these pumps could be affected if the device becomes contaminated.
Check for the batch number 3000064725 on the pump's label. The product is part of the Maquet Getinge-BEQ-TOP 41200 ECC 1/4 PUMP PAC series.
Look for the batch number 3000064725 on the pump's label to confirm if it is affected.
The pump's closed stopcock design may prevent proper humidity and gas flow during sterilization, risking contamination.
Check the batch number on the pump's label. If it is 3000064725, contact Maquet for further instructions.
The pump may not be safe to use if it has the affected batch number, as it could lead to contamination during sterilization.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1553-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1553-2019 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.
