Home / Recalls / Medical Devices
Maquet Medical Systems USA recalls QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Model Item No. HMO
Recalled June 7, 2023 · FDA recall Z-1659-2023 · Maquet Medical Systems USA
Hazard
Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may result in inflammation, infection, sepsis, and ischemia. · FDA Class II
Units
0 (US)
Sold at
Nationwide domestic distribution
Description
Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may result in inflammation, infection, sepsis, and ischemia.
Product
QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 70000-USA 701067820 HMO 71000-USA 701067823 BEQ-HMO 71000-USA 701067829
Manufacturer(s)
Maquet Medical Systems USA
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →