Maquet recalls specific ECC 3/8 tubing sets due to potential sterility issues during sterilization. The closed stopcock design may prevent proper humidity and gas flow, risking contamination. Affected units have batch numbers 3000065224 or 3000074124.
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 3/8 tubing sets 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 tubing's closed stopcock and non-vented cap design 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 contaminated medical devices.
Healthcare professionals using these specific tubing sets for extracorporeal circulation. Patients receiving treatments with improperly sterilized equipment are at potential risk.
Check for the model 'Maquet Getinge-BEQ-TOP 25500 ECC 3/8 w/QiD' with batch numbers 3000065224 or 3000074124. The product is sold under the brand Maquet.
Identify the batch number on the product label to confirm if it matches 3000065224 or 3000074124.
The closed stopcock design may prevent proper humidity and ethylene oxide gas flow during sterilization, risking contamination of the equipment.
Batch numbers 3000065224 and 3000074124.
The recall does not require immediate discontinuation; however, affected units should be checked for the specific batch numbers.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1521-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1521-2019 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.
