Cardinal Health Jackson-Pratt Drain Recalled for Multiple Performance Issues
Cardinal Health is recalling Jackson-Pratt Channel Drains due to multiple performance issues including dull trocars, lack of radiopacity, reduced flexibility, and broken tips. The affected devices were distributed worldwide.
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 recall involving a surgical device with multiple reported performance defects (broken tips, dull trocars, lack of radiopacity, reduced flexibility). No hospitalizations or injuries have been reported in the source text, placing this at the High level—a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Cardinal Health is recalling the Jackson-Pratt Channel Drain, 7 mm (Reference JP-2216), manufactured by Cardinal Health 200, LLC. The recall affects devices with lot numbers N210278, N210347, N210460, N210468, N210469, N210543, N220050, N220099, N220139, and N220163.
Cardinal Health received multiple complaints regarding performance issues with these drains. The reported problems include lack of radiopacity (inability to visualize the drain on X-rays), dull trocars that impact product performance, lack of flexibility affecting proper placement, and broken wound tips.
The recalled devices were distributed worldwide, including throughout the United States, Canada, Saudi Arabia, Singapore, and Hong Kong. This recall is classified as a Class II recall by the FDA.
The recalled product
- Product
- Cardinal Health Jackson-Pratt Channel Drain, 7 mm, REF JP-2216
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Surgical Drain
- Hazard
- broken-tip
- dull-trocar
- lack-of-radiopacity
- reduced-flexibility
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 50885380182530(cs)
- 20885380182539(ea)
- Lot Numbers: N210278
- N210347
- N210460
- N210468
- N210469
- N210543
- N220050
- N220099
- N220139
- N220163
Distribution
Distributed nationwide across the United States.
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