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Maquet Medical Systems USA recalls QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 3
Recalled June 7, 2023 · FDA recall Z-1655-2023 · 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 Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 30000-USA 701070384 HMO 31000-USA 701070388
Manufacturer(s)
Maquet Medical Systems USA
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →