Maquet recalls Getinge-BEQ-T 5908 TCH HLS ancillary material 701064590 due to potential sterility issues during sterilization. Affected units have batch numbers starting with 3000071399.
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 configuration may trap humidity and ethylene oxide gas, preventing proper sterility assurance. This could lead to contamination if the tubing is used without being fully sterile.
Healthcare professionals using the Getinge-BEQ-T 5908 TCH HLS tubing set for extracorporeal circulation. Patients receiving such treatments are at risk if the tubing isn't properly sterilized.
Check for the model number 701064590 on the tubing set. Affected units have batch numbers starting with 3000071399.
Look for the model number 701064590 and batch numbers starting with 3000071399 on the tubing set.
The recall addresses a potential sterility issue during sterilization, which could lead to infections if the tubing isn't properly sterilized. However, the hazard is not described as causing serious injury in normal use.
The recall record does not specify a remedy, so no action is required beyond checking if you have the affected model and batch numbers.
Check for the model number 701064590 and batch numbers starting with 3000071399 on the tubing set.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1557-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1557-2019 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.
