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Cook Incorporated recalls Pressure Monitoring Set, Single-lumen uncoated central venous catheter. RPN C-PMS-250, GPN G02838
Recalled July 20, 2022 · FDA recall Z-1362-2022 · 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. · FDA Class II
Units
11,451 units
Sold at
US Nationwide. Brazil, Canada,
Description
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.
Product
Pressure Monitoring Set, Single-lumen uncoated central venous catheter. RPN C-PMS-250, GPN G02838
Manufacturer(s)
Cook Incorporated
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →