Cardinal Health Jackson-Pratt Channel Drains Recalled for Multiple Performance Defects
Cardinal Health is recalling Jackson-Pratt Channel Drains due to performance defects including dull trocars, broken tips, and radiopacity issues. 921 units affected worldwide.
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: FDA Class II recall for a risk-of-harm surgical device. The defects (dull trocars, broken tips, reduced flexibility, lack of radiopacity) present significant operational risks. Source does not report hospitalizations or confirmed injuries, but the product performance issues constitute a clear risk of harm.
Plain-English summary
Cardinal Health 200, LLC is recalling Jackson-Pratt Channel Drains (15 Fr, model JP-2189) due to multiple performance defects. The issues include lack of radiopacity (visibility on X-rays), dull trocars that impair function, reduced flexibility, and broken wound tips.
The recall affects 921 units distributed worldwide including the United States, Canada, Saudi Arabia, Singapore, and Hong Kong. Affected lot numbers are N210278, N210368, N210423, N210460, N210468, N210543, N220050, N220099, N220139, and N220163.
Healthcare providers and patients using these drains should immediately inspect for defects. If defects are identified, the product should be replaced and Cardinal Health should be contacted for further assistance and replacement options.
The recalled product
- Product
- Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2189
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Surgical Drain
- Affected units
- 921
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 (12)
- UDI/DI 50885380182448(cs)
- 20885380182447(ea)
- Lot Numbers: N210278
- N210368
- N210423
- N210460
- N210468
- N210543
- N220050
- N220099
- N220139
- N220163
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 28 recalled by Cardinal Health 200, LLC 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.
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