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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 11,451
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.
Related recalls
Same manufacturer · Cook Incorporated
See all →- ModerateCook Williams Cystoscopic Injection Needles Recalled for Manufacturing Defect
FDA (Devices) · 2026-10-21
- CriticalAurous Centimeter Sizing Catheter Recalled for Marker Band Cracking Risk
FDA (Devices) · 2026-05-13
- SevereBeacon Tip Centimeter Sizing Catheter recalled for cracking marker bands
FDA (Devices) · 2026-05-13
- CriticalCook Centimeter Sizing Catheter recall due to marker band cracking
FDA (Devices) · 2026-05-13
- HighCook Medical CTO-18 wire guides labeled with overstated expiration dates
FDA (Devices) · 2026-04-15
Same hazard · excess coating
See all →- HighConvatec SLC Foley Catheters Recalled for Blocked Lumens
FDA (Devices) · 2014-03-26
- HighConvatec Recalls Toray Hydrocoat Foley Catheters Due to Blocked Lumen
FDA (Devices) · 2014-03-26
- HighConvatec Recalls Latex Foley Catheters Due to Blocked Lumen
FDA (Devices) · 2014-03-26
- HighMedline Sterile Foley Catheter Recalled for Blocked Lumen
FDA (Devices) · 2014-03-26
Similar recalls
- HighCook Inc. Recalls Pressure Monitoring Sets Due to Coating Occlusion Risk
FDA (Devices) · 2020-06-10
- HighCook Inc. Recalls Pressure Monitoring Trays Due to Coating Occlusion Risk
FDA (Devices) · 2020-06-10
- ModerateCook Inc. Recalls Femoral Artery Pressure Monitoring Sets for Labeling Error
FDA (Devices) · 2018-03-21
- SevereCook Inc. Recalls Radial Artery Pressure Monitoring Catheter Sets
FDA (Devices) · 2016-03-02
- SevereCook Inc. Recalls Single Lumen Pressure Monitoring Sets Due to Tip Fracture
FDA (Devices) · 2016-03-02
- SevereCook Inc. Recalls Femoral Artery Pressure Monitoring Catheters Due to Tip Fracture Risk
FDA (Devices) · 2016-03-02