Jackson-Pratt Surgical Drain Recalled Due to Performance Defects
Cardinal Health is recalling 4,372 Jackson-Pratt Channel Drains due to multiple performance issues: lack of radiopacity, dull trocars, reduced flexibility, and broken wound tips.
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 with multiple performance defects (lack of radiopacity, dull trocars, reduced flexibility, broken tips) that represent a risk of harm to proper device function. No injuries or hospitalizations are reported, placing this in the High category per the rubric for risk-of-harm products without reported injury.
Plain-English summary
Cardinal Health is recalling 4,372 Jackson-Pratt Channel Drains (Model 19 Fr, REF JP-2232) distributed worldwide due to multiple reported performance issues.
The reported issues include lack of radiopacity in the wound drains (preventing visualization on X-rays), dull trocars that impact device performance, reduced flexibility of the drains, and broken wound tips. These defects may interfere with proper device function or placement verification during surgical procedures.
The affected products are identified by lot numbers: N210278, N210368, N210423, N210460, N210468, N210469, N210543, N220050, N220099, N220139, and N220163. The drains were distributed in the United States, Canada, Saudi Arabia, Singapore, and Hong Kong.
The recalled product
- Product
- Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2232
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Surgical Drain
- Hazard
- trocar-defect
- radiopacity-defect
- flexibility-defect
- broken-tip
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 50885380182646(cs)
- 20885380182645(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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