Maquet recalls specific child-sized tubing sets for potential sterility issues during sterilization. The closed stopcock design may prevent proper humidity and gas flow, risking contamination. Affected units have batch numbers 3000049556 or 3000067468.
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 child-sized tubing sets that could become contaminated during sterilization if not properly handled. This affects medical devices used in extracorporeal circulation (ECC) procedures.
The tubing's closed stopcock 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 contamination of the device.
Healthcare providers using the specific child-sized tubing sets for extracorporeal circulation procedures. Children receiving such treatments are at higher risk due to the medical context.
Check for batch numbers 3000049556 or 3000067468 on the tubing sets. The product is labeled as 'Maquet Getinge-BEQ-TOP 21502# Med City Childr' with material code 701050060.
Look for batch numbers 3000049556 or 3000067468 on the tubing sets.
The recalled tubing is the Maquet Getinge-BEQ-TOP 21502# Med City Childr with material code 701050060.
The closed stopcock design may prevent proper humidity and ethylene oxide gas flow during sterilization, risking contamination.
Check for batch numbers 3000049556 or 3000067468 on the tubing sets.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1506-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1506-2019 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.
