Maquet recalls Getinge-BEQ-TOP 8075 S-Quadrox iD Plus Pack wRF3 (709000460) 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 a specific blood circulation device because improper sterilization could lead to contamination. This affects medical devices used in extracorporeal circulation procedures.
During sterilization, the device's closed stopcock configuration may trap humidity and ethylene oxide gas, preventing proper sterility assurance. This could lead to contamination of the device after sterilization.
Healthcare professionals using the Getinge-BEQ-TOP 8075 S-Quadrox iD Plus Pack wRF3 device for extracorporeal circulation procedures. Patients undergoing such treatments are at risk if the device fails to maintain sterility.
Check for the model number 8075 S-Quadrox iD Plus Pack wRF3 and material code 709000460. Affected units have batch numbers starting with 3000081747.
Verify the model number and material code on the device to confirm if it matches the recalled items.
The recalled model is Maquet Getinge-BEQ-TOP 8075 S-Quadrox iD Plus Pack wRF3 with material code 709000460.
Check for the model number 8075 S-Quadrox iD Plus Pack wRF3 and material code 709000460, with batch numbers starting with 3000081747.
The recall record does not specify a remedy, so no action is required beyond checking if the device is affected.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1623-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1623-2019 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.
