Maquet recalls pediatric packs with batch numbers 3000046123 and 3000059176 due to potential sterility issues during sterilization. Affected units may not meet sterility standards after processing.
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 pediatric packs that could fail to meet sterility standards after sterilization. This risk affects medical devices used in extracorporeal circulation procedures.
During sterilization, the closed stopcock design may trap humidity and ethylene oxide gas, preventing proper sterility assurance. This could lead to contamination of the device after processing.
Healthcare providers using the pediatric packs for extracorporeal circulation procedures are most at risk. Patients receiving these devices during sterilization may be affected.
Check for batch numbers 3000046123 or 3000059176 on the pediatric packs. The product is labeled as Maquet Getinge-BEQ-T 8069 Pediatric Pack with material code 701064965.
Look for batch numbers 3000046123 or 3000059176 on the pediatric packs.
The closed stopcock design may prevent humidity and ethylene oxide gas from flowing into the fluid path during sterilization, potentially compromising sterility assurance.
Check for batch numbers 3000046123 or 3000059176 on the Maquet Getinge-BEQ-T 8069 Pediatric Pack with material code 701064965.
The recall record does not specify a remedy, so contact the manufacturer 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-1565-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1565-2019 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.
