Maquet recalls Getinge-BEQ-TOP 47800 STRINGFELLOW PED material 701066583 due to potential sterility issues during sterilization. Affected units have batch numbers 3000046122 or 3000062040.
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 cardiovascular tubing set because it may not maintain sterility during sterilization. This could lead to infections if the equipment is used without proper sterility.
During sterilization, the tubing's closed stopcock design may trap humidity and ethylene oxide gas, preventing proper sterility assurance. This could lead to infections if the tubing isn't fully sterilized before use.
Healthcare professionals using this tubing set for extracorporeal circulation (ECC) in medical procedures. Patients using the equipment are at risk if the tubing isn't properly sterilized.
Check for the product name 'Getinge-BEQ-TOP 47800 STRINGFELLOW PED' with material code 701066583. Affected units have batch numbers 3000046122 or 3000062040.
Look for the material code 701066583 and batch numbers 3000046122 or 3000062040 on the tubing set.
The recall indicates a potential sterility risk during sterilization, so it should not be used until the remedy is applied.
Batch numbers 3000046122 and 3000062040 are affected.
If the tubing isn't properly sterilized due to the design, it could lead to infections.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1580-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1580-2019 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.
