Cook Inc. Recalls Pressure Monitoring Trays Due to Coating Occlusion Risk
Cook Inc. is recalling 1,899 Pressure Monitoring Trays because excess coating material on the needle component could cause occlusion.
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: The recall involves a medical device with a risk of harm (occlusion) where no specific injuries or illnesses have been reported in the source text, fitting the criteria for a High severity score.
Plain-English summary
Cook Inc. is recalling 1,899 units of the Pressure Monitoring Tray, C-PMSY, G02854. The recall affects specific lot numbers, including 9402033, 9406111, 9782916, 9789983, 9824026, and others added on July 7, 2020.
The recall was initiated because the Pressure Monitoring Set and Tray may contain excess coating material on the outside and/or interior of the needle component. This excess material could cause occlusion, which may interfere with the device's function.
The affected products were distributed worldwide, including to numerous U.S. states. Healthcare facilities and users should stop using the affected lots and contact Cook Inc. for further instructions.
The recalled product
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 (18)
- Lot Numbers: 9402033
- 9406111
- 9782916
- 9789983
- 9824026 ***Added 7/7/20*** 9829655
- 9850622
- 9864806
- 9874004
- 9880413
- 9904717
- 9910200
- 9922162
- 9934864
- 9954321
- 9961179
- 10133951
- 10142269
- 10145133
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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