Maquet recalls specific ECC tubing sets due to potential sterility issues when sterilized. The closed stopcock design may prevent proper humidity and gas flow, risking contamination. Affected units have batch numbers starting with 3000083879.
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 tubing sets because their design may cause sterility problems during sterilization. This could lead to contaminated medical equipment if not properly sterilized, posing a risk to patient safety.
The tubing'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 equipment.
Healthcare professionals using the specific tubing sets for extracorporeal circulation (ECC) are most at risk. Patients receiving treatments with these sets could be affected if the equipment becomes contaminated.
Check for the model number '31603 CHKD 3/8" ECC' and batch numbers starting with '3000083879'. The product is sold under Maquet Getinge-BEQ-TOP.
Identify the model number '316003 CHKD 3/8" ECC' and batch numbers starting with '3000083879' to confirm if your item is affected.
The closed stopcock design may prevent proper humidity and ethylene oxide gas flow during sterilization, risking contamination of the equipment.
The recall record does not specify a remedy, so check with Maquet directly for guidance.
The recall indicates a potential sterility issue, but no specific injury mechanism is described. This is a low-risk hazard.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1626-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1626-2019 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.
