Maquet recalls specific Getinge-BEQ-TOP 1601#QUADROX iD models due to potential sterility issues during sterilization. Affected units may not maintain proper sterility assurance levels if not handled correctly.
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 certain Getinge-BEQ-TOP 1601#QUADROX iD models because their tubing design might fail to ensure sterility during sterilization. This could lead to contamination risks if the equipment is used in medical procedures.
The closed stopcock design in these tubing sets may prevent humidity and ethylene oxide gas from flowing into the fluid path during sterilization. This could compromise the sterility assurance level, potentially leading to contamination of medical equipment.
Healthcare professionals using the Getinge-BEQ-TOP 1601#QUADROX iD models for extracorporeal circulation. Patients receiving treatments with these devices may be at risk if the equipment is not properly sterilized.
Check for the model number Getinge-BEQ-TOP 1601#QUADROX iD with pack material 701052285. Affected units have batch numbers 3000048235, 3000056129, 3000059730, 3000065496, 3000070700, or 3000073428.
Identify the model number Getinge-BEQ-TOP 1601#QUADROX iD and pack material 701052285 with the listed batch numbers.
The closed stopcock design may prevent proper humidity and ethylene oxide gas flow during sterilization, risking contamination of medical equipment.
Check the model and batch numbers to see if your unit is affected; contact Maquet for further instructions.
The recall record does not specify a remedy or fix for this issue.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1518-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1518-2019 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.
