Cardinal Health Jackson-Pratt Channel Drain recall for performance defects
Cardinal Health is recalling Jackson-Pratt Channel Drains due to performance defects: dull trocars, broken tips, lack of flexibility, and radiopacity issues. The 8,563 affected units 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: FDA Class II medical device recall with documented structural defects that could impair function. No reported illnesses or injuries in the source material. This qualifies as a risk-of-harm product where injury has not yet been reported, meeting the Score 3 (High) criterion.
Plain-English summary
Cardinal Health 200, LLC is recalling the Jackson-Pratt Channel Drain, 19 Fr, model REF JP-2231, a surgical device used for wound drainage following surgical procedures. The recall affects approximately 8,563 units that were distributed worldwide, including the United States, Canada, Saudi Arabia, Singapore, and Hong Kong.
Cardinal Health received multiple complaints regarding performance issues with the affected drains. The identified issues include lack of radiopacity in the wound drain (meaning the drain cannot be clearly visualized on X-rays), dull trocars that may impact insertion, lack of flexibility in the drain tubing, and broken wound tips. These defects may affect the device's intended function and performance.
Healthcare facilities and individuals using or storing these drains should stop use and contact Cardinal Health for guidance on replacement or return procedures. The affected lot numbers are: N210278, N210347, N210368, N210423, N210460, N210468, N210469, N210543, N220050, N220099, N220139, and N220163. For complete information about this recall, consult the FDA's notice using the recall reference number Z-0989-2023.
The recalled product
- Product
- Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2231
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Surgical Drain
- Hazard
- broken-tips
- dull-trocars
- 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 (14)
- UDI/DI 50885380182639(cs)
- 20885380182638(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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