Cardinal Health Jackson-Pratt Channel Drain Recalled for Performance Defects
Cardinal Health Jackson-Pratt Channel Drains (19 Fr, REF JP-2230) are recalled due to performance issues including lack of radiopacity, dull trocars, reduced flexibility, and broken tips affecting 29,515 units.
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 a Class II FDA medical device recall with reported performance defects (dull trocars, broken tips, lack of flexibility) that could affect device function and patient care. No illnesses or injuries have been reported, but the defects present a risk of harm to patients using the drains.
Plain-English summary
Cardinal Health 200, LLC is recalling Cardinal Health Jackson-Pratt Channel Drains (19 Fr, REF JP-2230) worldwide. The recall affects 29,515 units distributed in the United States, Canada, Saudi Arabia, Singapore, and Hong Kong.
The recall was initiated after Cardinal Health received multiple complaints regarding performance issues with the drains. Reported defects include lack of radiopacity in the wound drains, dull trocars that impact product performance, reduced flexibility of the wound drains, and broken wound tips.
Cardinal Health Jackson-Pratt Channel Drains are used for surgical wound drainage. The reported defects could impact proper drain function and visualization during use. Patients or healthcare providers who have these drains should contact their healthcare provider or Cardinal Health for guidance.
Affected lot numbers are: N210278, N210347, N210368, N210423, N210460, N210468, N210469, N210543, N220050, N220099, N220139, N220163.
The recalled product
- Product
- Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2230
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Surgical Drain
- Hazard
- radiopacity-defect
- trocar-defect
- flexibility-defect
- broken-tips
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 (14)
- UDI/DI 50885380182622(cs)
- 20885380182621(ea)
- Lot Numbers: N210278
- N210347
- N210368
- N210423
- N210460
- N210468
- N210469
- N210543
- N220050
- N220099
- N220139
- N220163
Distribution
Distributed nationwide across the United States.
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