Maquet recalls Getinge-BEQ-TOP 380:002 Adult Specialty Material due to potential sterility issues during sterilization. Affected units have batch numbers starting with 3000055504. Contact for remedy details.
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 adult specialty material used in extracorporeal circulation (ECC) systems because sterilization may not properly ensure sterility. This could lead to infections if the equipment is used without proper sterility.
During sterilization, the closed stopcock design may trap humidity and ethylene oxide gas, preventing proper sterility assurance. This could lead to infections if the material is used without adequate sterility.
Healthcare professionals using this material for extracorporeal circulation systems. Patients using these systems are at risk if the material is not properly sterilized.
Check for batch numbers starting with 3000055504 on the Maquet Getinge-BEQ-TOP 38002 Adult Specialty Material. This product is used in extracorporeal circulation systems.
Look for batch numbers starting with 3000055504 on the product label.
The Maquet Getinge-BEQ-TOP 38002 Adult Specialty Material used in extracorporeal circulation systems.
Batch numbers starting with 3000055504.
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-1541-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1541-2019 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.
