Maquet recalls BEQ-TOP 5900 TCH 3/8 Quadrox-iD Pack material 701050228R01 due to potential sterility issues during sterilization. Affected units have batch numbers 3000077553 and 3000084779.
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 pack because its design might not properly handle sterilization, risking infection. This affects medical devices used in surgeries and other critical care settings.
During sterilization, the closed stopcock configuration may trap humidity and ethylene oxide gas, preventing proper sterility assurance. This could lead to contamination of the device and infection risks for patients.
Healthcare professionals using this device during surgeries or critical care. Patients receiving treatments with this device are at risk of infection if the sterilization process fails.
Check for batch numbers 3000077553 or 3000084779 on the BEQ-TOP 5900 TCH 3/8 Quadrox-iD Pack. The product is sold under Maquet Cardiovascular, LLC.
Look for batch numbers 3000077553 or 3000084779 on the device packaging.
The device may not be sterile after sterilization due to design issues, so it should not be used until the recall is addressed.
Check the batch numbers on the device packaging. If they match 3000077553 or 3000084779, contact Maquet for instructions.
Patients using this device during surgery or critical care could face infection risks if the sterilization process fails.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1637-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1637-2019 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.
