Cardinal Health Jackson-Pratt Channel Drains Recalled for Performance Defects
Cardinal Health is recalling 1,150 Jackson-Pratt Channel Drains due to multiple performance defects including lack of radiopacity, dull trocars, reduced flexibility, and broken tips affecting post-surgical wound drainage.
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 identified performance defects in a surgical wound drain but no reported illnesses, injuries, or deaths. The device defects represent a risk of harm to patients undergoing post-surgical wound management, meeting criteria for High severity.
Plain-English summary
Cardinal Health 200, LLC is recalling 1,150 Jackson-Pratt Channel Drains (10 Fr, REF JP-2186) due to multiple performance defects. The recalled devices have lot numbers N210278, N210368, N210423, N210460, N210468, N210469, N210543, N220050, N220099, N220139, and N220163.
The drains were identified as having several performance issues: lack of radiopacity (visibility on X-ray imaging), dull trocars that impact insertion performance, reduced flexibility, and broken wound tips. These defects can affect the device's ability to provide proper post-surgical wound drainage.
The affected devices were distributed worldwide, including to the United States, Canada, Saudi Arabia, Singapore, and Hong Kong. Hospitals and healthcare facilities that have stocked these drains should verify their inventory against the provided lot numbers.
The recalled product
- Product
- Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2186
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Surgical Drain
- Hazard
- radiopacity-defect
- trocar-defect
- flexibility-defect
- tip-defect
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 50885380182417(cs)
- 20885380182416(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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