Cardinal Health Jackson-Pratt Channel Drains Recalled for Multiple Performance Defects
Cardinal Health Jackson-Pratt Channel Drains are recalled for performance defects including dull trocars, broken tips, lack of flexibility, and lack of radiopacity. 220 units are affected.
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: FDA Class II recall with reported performance defects in a surgical drainage device. No illnesses, injuries, or hospitalizations have been reported, meeting the criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Cardinal Health Jackson-Pratt Channel Drain, 10 mm (REF JP-2213) is being recalled. The product is a surgical wound drainage device. A total of 220 units are affected.
The recall was initiated due to multiple performance issues with the device. Cardinal Health received complaints regarding lack of radiopacity in the wound drains, dull trocars that impact product performance, lack of flexibility of the wound drains, and broken wound tips.
The affected units have been distributed worldwide, including throughout the United States, Canada, Saudi Arabia, Singapore, and Hong Kong. The recalled lot numbers are N210278, N210368, N210423, N210460, N210468, N210469, N210543, N220050, N220099, N220139, and N220163.
Healthcare facilities and users should verify the lot numbers of Jackson-Pratt Channel Drains in their inventory and quarantine any affected units. For more information or questions, contact Cardinal Health or the FDA.
The recalled product
- Product
- Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2213
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Surgical Drain
- Hazard
- dull-trocar
- broken-tip
- lack-of-flexibility
- lack-of-radiopacity
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 (13)
- UDI/DI 50885380182509(cs)
- 20885380182508(ea)
- Lot Numbers: N210278
- N210368
- N210423
- N210460
- N210468
- N210469
- N210543
- N220050
- N220099
- N220139
- N220163
Distribution
Distributed nationwide across the United States.
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