Maquet recalls Rotaflow Pack material 709000424 due to potential sterility issues during sterilization. Affected units have batch numbers starting with 3000065091.
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 a specific Rotaflow Pack model because improper sterilization could compromise sterility. This affects medical devices used in extracorporeal circulation procedures.
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 device, potentially leading to infections.
Healthcare professionals using the Rotaflow Pack for extracorporeal circulation procedures are most at risk. Patients receiving such treatments may be affected if the device fails to maintain sterility.
Check for the Rotaflow Pack model with material code 709000424 and batch numbers starting with 3000065091. The product was sold by Maquet Cardiovascular, LLC.
Identify the material code (709000424) and batch number (starting with 3000065091) on the device.
The recalled product is the Maquet Getinge-BEQ-T 57000 Rotaflow Pack with material code 709000424.
Batch numbers starting with 3000065091 are affected.
The recall record does not specify a remedy.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1617-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1617-2019 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.
