Cardinal Health Jackson-Pratt Channel Drain Recalled for Performance Defects
Cardinal Health is recalling Jackson-Pratt Channel Drains (10 mm) due to performance issues including lack of radiopacity, dull trocars, reduced flexibility, and broken wound tips that may impair drain function.
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 involving risk-of-harm performance defects in a surgical device used in post-operative care. No illnesses or injuries have been reported in the source text, limiting the classification to High rather than Severe.
Plain-English summary
Cardinal Health 200, LLC is recalling 3,550 units of the Jackson-Pratt Channel Drain, 10 mm (REF JP-2214) due to multiple performance defects identified during use.
The recalled drains exhibit the following issues: lack of radiopacity (making drains non-visible on X-rays), dull trocars that impair insertion performance, reduced flexibility that limits proper positioning, and broken wound tips that may fragment. These defects may prevent the drain from functioning properly during post-operative wound management.
The product was 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.
Customers possessing this product should discontinue use and contact Cardinal Health for instructions on device return or replacement.
The recalled product
- Product
- Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2214
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Surgical Drain
- Hazard
- radiopacity-defect
- trocar-defect
- flexibility-defect
- tip-breakage
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 50885380182516(cs)
- 20885380182515(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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