Recall Z-2203-2020— Cook Inc.
Class II · Terminated
Class II FDA medical device recall by Cook Inc., initiated 2020-04-30, terminated 2021-03-29. FDA's recall record names no specific 510(k) clearance for this event. Product: Pressure Monitoring Set, C-PMS, G02838. Reason: The Pressure Monitoring Set and Tray may contain excess coating material on the outside and/or interior of the needle component which could cause occlusion..
- Recalling firm
- Cook Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-04-30
- Terminated
- 2021-03-29
- Firm location
- Bloomington, IN, United States
Product description
Pressure Monitoring Set, C-PMS, G02838
Reason for recall
The Pressure Monitoring Set and Tray may contain excess coating material on the outside and/or interior of the needle component which could cause occlusion.
Data sourced from openFDA. This site is unofficial and independent of the FDA.