Pressure Monitoring Sets with Excess Coating Pose Embolism Risk
Cook Incorporated is recalling approximately 11,451 Pressure Monitoring Sets because excess coating material on the needle component may enter the bloodstream, potentially causing pulmonary embolism or ischemia.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall with potential for serious adverse outcomes including pulmonary embolism and ischemia. The source text does not report any illnesses or injuries. The product meets the rubric criterion for High severity as a risk-of-harm device where injury has not yet been reported.
Plain-English summary
Cook Incorporated is recalling 11,451 units of Pressure Monitoring Set, Single-lumen uncoated central venous catheter (RPN C-PMS-250, GPN G02838) distributed nationwide in the United States, as well as in Canada and Brazil.
The products may contain excess coating material on the outside and/or interior of the needle component.
Potential adverse events associated with use of an affected product include a delay in the procedure, a prolonged procedure, or particulate material entering the bloodstream, which may result in pulmonary embolism or ischemia.
The recalled product
- Product
- Pressure Monitoring Set, Single-lumen uncoated central venous catheter. RPN C-PMS-250, GPN G02838
- Manufacturer
- Cook Incorporated
- Hazard
- excess-coating
- pulmonary-embolism
- ischemia
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UDI-DI: (01)00827002028388
- Lot Numbers: 9665716
- 9679942
- 9686540
- 9686549
- 9689250
- 9689343
- 9692548
- 9692549
- 9699716
- 9699717
- 9705738
- 9709183
- 9712150
- 9712373
- 9736455
- 9742510
- 9746575
- 9746716
- 9760404
Distribution
Distributed nationwide across the United States.
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