Maquet recalls Getinge-BEQ-T 16405 LIVER TX INFUSION tubing with batch numbers 3000055324 and 3000061509 due to potential sterility issues during sterilization.
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 liver infusion tubing models because improper sterilization could lead to contamination. This affects patients receiving extracorporeal circulation treatments.
During sterilization, the tubing's closed stopcock design may trap humidity and ethylene oxide gas, preventing proper sterility assurance. This could lead to contamination of the fluid path, risking infections in patients.
Healthcare professionals using the Getinge-BEQ-T 16405 LIVER TX INFUSION tubing for extracorporeal circulation treatments. Patients undergoing such procedures are at risk if the tubing is not properly sterilized.
Check for batch numbers 3000055324 or 3000061509 on the tubing. The product is labeled as Getinge-BEQ-T 16405 LIVER TX INFUSION.
Look for batch numbers 3000055324 or 3000061509 on the tubing.
The recall does not specify if the product is safe to use; it indicates a potential sterility risk during sterilization.
The recall does not provide specific action steps; only batch numbers are listed for identification.
Check for batch numbers 3000055324 or 3000061509 on the Getinge-BEQ-T 16405 LIVER TX INFUSION tubing.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1576-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1576-2019 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.
