FDA-Device2023-06-07Class II
Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass Model Item No. VKMO 10000-USA 701070441 VKMO 11000-USA 701070445
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.
Sold states
Nationwide domestic distribution
Affected count
0 (US)
Manufactured in
45 Barbour Pond Dr, N/A, Wayne, NJ, United States
Products
Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass Model Item No. VKMO 10000-USA 701070441 VKMO 11000-USA 701070445
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1661-2023Don't want to check this manually?
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