Cardinal Health Jackson-Pratt Channel Drains recalled for performance defects
Cardinal Health is recalling 22,847 units of Jackson-Pratt Channel Drains due to performance issues including dull trocars, broken tips, lack of flexibility, and lack of radiopacity.
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 of a medical device used in post-surgical wound management. While no injuries or illnesses have been reported, the performance defects—including broken tips and lack of visibility on imaging—create risk of harm during surgical drainage procedures, meeting the criteria for High severity.
Plain-English summary
Cardinal Health 200, LLC is recalling the Jackson-Pratt Channel Drain, 24 Fr (REF JP-2234), a surgical wound drainage device. Approximately 22,847 units have been recalled.
The company has received multiple complaints regarding performance issues with the product, including: lack of radiopacity (making the drain invisible on X-rays), dull trocars that impair insertion, reduced flexibility of the drain material, and broken wound drain tips.
The affected drains were distributed worldwide, including throughout the United States, Canada, Saudi Arabia, Singapore, and Hong Kong. Affected lot numbers are: N210278, N210347, N210368, N210423, N210460, N210468, N210469, N210543, N220050, N220099, N220139, and N220163.
Healthcare facilities should inspect drains from these lot numbers and consult with Cardinal Health or their local healthcare regulatory authority regarding replacement or alternative products. Drains should not be used if performance issues are suspected.
The recalled product
- Product
- Cardinal Health Jackson-Pratt Channel Drain, 24 Fr, REF JP-2234
- Manufacturer
- Cardinal Health 200, LLC
- Hazard
- product-malfunction
- broken-components
- lack-of-radiopacity
- improper-insertion
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 50885380182660(cs)
- 20885380182669(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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