Pressure Monitoring Set, Single-lumen uncoated central venous catheter. RPN C-PMS-250, GPN G02838
Reported: July 20, 2022 Initiated: May 25, 2022 #Z-1362-2022
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.
Details
- Recalling Firm
- Cook Incorporated
- Units Affected
- 11,451 units
- Distribution
- US Nationwide. Brazil, Canada,
- Location
- Bloomington, IN
Frequently Asked Questions
What product was recalled? ▼
Pressure Monitoring Set, Single-lumen uncoated central venous catheter. RPN C-PMS-250, GPN G02838. Recalled by Cook Incorporated. Units affected: 11,451 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 20, 2022. Severity: Moderate. Recall number: Z-1362-2022.
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