Maquet recalls specific large ECC sets due to potential sterility issues during sterilization. The closed stopcock design may prevent proper humidity and gas flow, risking contamination. Affected units include batch numbers 3000041128 through 3000071818.
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 large extracorporeal circulation (ECC) sets because their design might cause sterility problems during sterilization. This could lead to contaminated medical equipment if not properly sterilized, which is dangerous for patients.
The closed stopcock and non-vented cap design may block humidity and ethylene oxide gas from flowing into the fluid path during sterilization. This prevents proper sterility assurance, potentially leading to contaminated equipment that could harm patients.
Healthcare professionals using these sets for extracorporeal circulation procedures are most at risk. Patients receiving treatment with these sets could be exposed to contamination.
Check for the product name 'Maquet Getinge-BEQ-T 5211 LARGE ECC SET' with material code 701064560. Affected units include batch numbers 3000041128, 3000045731, 3000050577, 3000052947, 3000054617, 3000054955, 3000057631, and 3000071818.
Identify the batch number on the product label to confirm if it's affected.
Reach out to Maquet Cardiovascular for guidance on next steps if you have an affected unit.
The closed stopcock and non-vented cap design may prevent proper humidity and ethylene oxide gas flow during sterilization, risking contamination of the equipment.
Batch numbers 3000041128, 3000045731, 3000050577, 3000052947, 3000054617, 3000054955, 3000057631, and 3000071818.
The recall does not require immediate discontinuation; healthcare professionals should check batch numbers and contact Maquet for guidance.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1556-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1556-2019 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.
