Maquet recalls specific pediatric cardiac surgery 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 listed in the recall notice.
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 pediatric cardiac surgery 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 and non-vented cap design 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 contaminated equipment.
Healthcare professionals using pediatric cardiac surgery equipment are most at risk. Patients undergoing surgery with these specific tubing sets could be exposed to contaminated equipment.
Check for the batch numbers: 3000044424, 3000046488, 3000049459, 3000055093, or 3000060357. The product is labeled as Maquet Getinge-BO-T 46201 Small Pediatric Cardiac Surge Material.
Verify your tubing set's batch number against the listed numbers: 3000044424, 3000046488, 3000049459, 3000055093, or 3000060357.
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 3000044424, 3000046488, 3000049459, 3000055093, and 3000060357 are affected.
The recall notice does not specify a remedy, so affected users should check with the manufacturer for further instructions.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1605-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1605-2019 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.
