FDA-Device2023-06-07Class II
Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass Model Item No. VKMO 10000-USA 701070441 VKMO 11000-USA 701070445
Maquet Medical Systems USA
Hazard
1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's sterile pouch. 2. Product packaging may exhibit holes, cracks, dents, and crushed areas. Both issues may compromise the sterile barrier of the packaging, and exposure to non-sterile product may result in inflammation, infection, sepsis, and ischemia.
Sold states
Domestic distribution nationwide.
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-1642-2023Don't want to check this manually?
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