Maquet recalls Getinge-BEQ-T-22800 tubing sets with batch numbers 3000046489 and 3000055506 due to potential sterility issues during sterilization. Affected units may not meet sterility standards 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 specific tubing sets used in extracorporeal circulation (ECC) because they might not stay sterile after sterilization. This could lead to infections if the equipment is used without proper sterility.
During sterilization, the tubing's design may trap humidity and ethylene oxide gas, preventing the system from maintaining sterility. This could allow bacteria to grow in the tubing, increasing infection risk during medical procedures.
Healthcare professionals using these tubing sets for heart-lung machines during surgery or medical procedures are most at risk. Patients receiving these devices could face infection if the tubing isn't properly sterilized.
Check for batch numbers 3000046489 or 3000055506 on the tubing sets. These are part of the Maquet Getinge-BEQ-T-22800 model used in extracorporeal circulation systems.
Look for batch numbers 3000046489 or 3000055506 on the tubing sets.
The tubing sets may not maintain sterility after sterilization due to their design, which can trap humidity and ethylene oxide gas.
Check the batch numbers on the tubing sets. If they match 3000046489 or 3000055506, contact Maquet for further instructions.
The recall addresses potential infection risk, not direct injury. The hazard is related to sterility, not physical harm.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1503-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1503-2019 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.
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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.
