Cook Inc. Recalls Pressure Monitoring Sets Due to Coating Occlusion Risk
Cook Inc. is recalling 6,792 Pressure Monitoring Sets because excess coating material on the needle component could cause occlusion.
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: The recall involves a medical device defect (occlusion) that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Cook Inc. is recalling 6,792 units of the Pressure Monitoring Set, C-PMS, G02838. The recall is due to a defect where the needle component may contain excess coating material on the outside and/or interior, which could cause occlusion.
The affected products were distributed worldwide, including to numerous U.S. states. The recall covers specific lot numbers listed in the agency's official documentation.
Healthcare providers and consumers should stop using the affected Pressure Monitoring Sets and contact Cook Inc. for instructions on return or replacement.
The recalled product
- Product
- Pressure Monitoring Set, C-PMS, G02838
- Manufacturer
- Cook Inc.
- Hazard
- Affected units
- 6,792
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)
- Lot Numbers: 8910219
- 8937938
- 8951879
- 8979177
- 8990088
- 9007566
- 9008052
- 9039794
- 9351985
- 9351986
- 9354853
- 9359896
- 9367663
- 9372621
- 9380316
- 9381545
- 9386056
- 9386351
- 9389523
- 9395471
Distribution
Part of a larger recall action
This product is one of 2 recalled by Cook Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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