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Maquet Medical Systems USA recalls Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass Model
Recalled June 7, 2023 · FDA recall Z-1661-2023 · 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
Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass Model Item No. VKMO 10000-USA 701070441 VKMO 11000-USA 701070445
Manufacturer(s)
Maquet Medical Systems USA
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →