FDA-Device2022-07-20Class II
Pressure Monitoring Set, Single-lumen uncoated central venous catheter. RPN C-PMS-250, GPN G02838
Cook Incorporated
Hazard
The products may contain excess coating material on the outside and/or interior of the needle component. Potential adverse events that may occur if an affected product is used include a delay in the procedure, a prolonged procedure, or particulate entering the bloodstream which may result in pulmonary embolism or ischemia.
Sold states
US Nationwide. Brazil, Canada,
Affected count
11,451 units
Manufactured in
750 N Daniels Way, Bloomington, IN, United States
Products
Pressure Monitoring Set, Single-lumen uncoated central venous catheter. RPN C-PMS-250, GPN G02838
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1362-2022Don't want to check this manually?
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