Maquet recalls specific ECC pump models due to potential sterility issues when sterilized. The closed stopcock design may prevent proper humidity and gas flow, risking contamination. Affected units include batch numbers 3000045174 through 3000074097.
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 configuration may block humidity and ethylene oxide gas from flowing into the fluid path during sterilization. This can compromise the sterility assurance level, potentially leading to contamination of the device and patient exposure.
Healthcare professionals using the Maquet Getinge-BEQ-TOP 41201 ECC 3/8 PUMP PAC model with batch numbers 3000045174 through 3000074097 are most at risk. Patients receiving these pumps could be exposed to contamination if the device fails to maintain sterility.
Check for the model 'Maquet Getinge-BEQ-TOP 41201 ECC 3/8 PUMP PAC' with batch numbers 3000045174, 3000049559, 3000057376, 3000063289, 3000069864, or 3000074097. These units were sold with specific batch numbers listed in the recall notice.
Identify the batch number on the pump's label to confirm if it is affected (3000045174, 3000049559, 3000057376, 3000063289, 3000069864, or 3000074097).
The pump's closed stopcock design may prevent proper humidity and ethylene oxide gas flow during sterilization, risking contamination and compromising sterility assurance.
Batch numbers 3000045174, 3000049559, 3000057376, 3000063289, 3000069864, and 3000074097 are affected.
No immediate stop is required, but affected units should be checked for batch numbers and handled with caution to avoid contamination risks.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1564-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1564-2019 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
