Maquet recalls pediatric CPB packs with batch 3000041540 due to potential sterility issues during sterilization. Affected units may not meet sterility standards if humidity/ethylene oxide gas cannot flow properly.
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 CPB packs with batch number 3000041540 because the tubing design might prevent proper humidity and gas flow during sterilization. This could lead to the packs not meeting sterility standards, which is critical for medical safety.
The closed stopcock and non-vented cap design may block humidity and ethylene oxide gas from flowing into the fluid path during sterilization. This could compromise the sterility assurance level (SAL) of the stopcock ports, potentially leading to infections if the equipment is used without proper sterility.
Healthcare providers using the Maquet Getinge-BEQ-T 4906 PEDIARIC CPB PACK with batch number 3000041540 are most at risk. This recall affects pediatric cardiac surgery equipment.
Check for the batch number 3000041540 on the Maquet Getinge-BEQ-T 4906 PEDIARIC CPB PACK. The product is sold as a pediatric cardiopulmonary bypass pack.
Identify the batch number on the pack to confirm if it matches 3000041540.
The recall indicates a potential sterility risk during sterilization, but the product may still be safe if used properly with the correct sterilization process. However, the specific batch number 3000041540 is affected.
The recall does not specify a remedy, so you should check the batch number and contact Maquet for further guidance if needed.
Look for the batch number 3000041540 on the Maquet Getinge-BEQ-T 4906 PEDIARIC CPB PACK.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1546-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1546-2019 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.
