Maquet recalls Getinge-BEQ-TOP 25503 TMC tubing sets with batch 3000074399 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 for extracorporeal circulation that could fail to maintain sterility during sterilization. This poses a risk of infection if used in medical procedures.
During sterilization, the tubing's closed stopcock design may trap humidity and ethylene oxide gas, preventing proper sterility assurance. This could lead to contamination if the tubing is used in medical procedures.
Healthcare professionals using these tubing sets for extracorporeal circulation procedures. Patients undergoing such treatments are at risk if the tubing is not properly sterilized.
Check for the model number 'Getinge-BEQ-TOP 25503 TMC' with batch number 3000074399. The product includes specific tubing sets for extracorporeal circulation.
Verify the model number and batch number on the tubing set to confirm if it is affected.
The recall indicates a potential sterility risk during sterilization, so affected units should not be used until the remedy is applied.
The recall does not specify a remedy, so contact Maquet directly for guidance on handling affected units.
Check for the model number 'Getinge-BEQ-TOP 25503 TMC' and batch number 3000074399.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1624-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1624-2019 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.
