Recall Z-1362-2022— Cook Incorporated
Class II · Completed
Class II FDA medical device recall by Cook Incorporated, initiated 2022-05-25. FDA's recall record names no specific 510(k) clearance for this event. Product: Pressure Monitoring Set, Single-lumen uncoated central venous catheter. RPN C-PMS-250, GPN G02838. Reason: 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..
- Recalling firm
- Cook Incorporated
- Classification
- Class II
- Status
- Completed
- Initiated
- 2022-05-25
- Firm location
- Bloomington, IN, United States
Product description
Pressure Monitoring Set, Single-lumen uncoated central venous catheter. RPN C-PMS-250, GPN G02838
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.