Maquet recalls specific Quadrox iD Pediatric Packs due to potential sterility issues during sterilization. Affected units may not maintain proper sterility assurance levels 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 certain Quadrox iD Pediatric Packs because their design may fail to ensure sterility during sterilization. This could lead to contaminated medical devices if used improperly.
During sterilization, the closed stopcock configuration may prevent humidity and ethylene oxide gas from flowing into the fluid path. This could compromise the sterility assurance level of the stopcock ports, potentially leading to contamination.
Healthcare providers using the recalled pediatric packs for extracorporeal circulation procedures are most at risk. Patients undergoing such treatments could be affected if the packs are used without proper sterility.
Check for the model number 37302 Quadrox iD Pediatric Pack with material code 7010651: 190. Affected units have batch numbers 3000069382 or 3000074502.
Verify the model number and batch numbers listed in the recall notice to confirm if your unit is affected.
The recalled product is the Maquet Getinge-BEQ-TOP 37302 Quadrox iD Pediatric Pack with material code 701065190.
Batch numbers 3000069382 and 3000074502 are affected.
The recall addresses a potential risk of compromised sterility during sterilization, which could lead to contaminated medical devices if used improperly.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1567-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1567-2019 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
