Cardinal Health Jackson-Pratt Channel Drain Recalled for Performance Defects
Cardinal Health is recalling Jackson-Pratt Channel Drains (7mm, REF JP-2210) for performance issues including lack of radiopacity, dull trocars, poor flexibility, and broken tips. Affected units may not function properly.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 for a surgical device with multiple performance defects that could impair proper function. No reported illnesses or injuries. This is a 'risk-of-harm product where injury has not yet been reported,' meeting the rubric criterion for severity score 3 (High).
Plain-English summary
Cardinal Health is recalling the Jackson-Pratt Channel Drain, 7 mm (Reference JP-2210), a surgical wound drain used post-operatively. Multiple complaints have been received regarding performance defects in these devices, including lack of radiopacity (visibility on X-rays), dull trocars (insertion needles) that impact insertion, insufficient flexibility of the drain, and broken wound tips.
The affected devices were distributed worldwide, including throughout the United States, Canada, Saudi Arabia, Singapore, and Hong Kong. Specific lot numbers affected include N210278, N210368, N210423, N210460, N210468, N210543, N220050, N220099, N220139, and N220163. Devices are identified by UDI/DI codes 50885380182479 (case) and 20885380182478 (each).
Healthcare providers and facilities that have received these devices should quarantine affected lot numbers and contact Cardinal Health 200, LLC for further instructions. Patients who have received these drains should contact their healthcare provider if they have concerns about their device.
The recalled product
- Product
- Cardinal Health Jackson-Pratt Channel Drain, 7 mm, REF JP-2210
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Surgical Drain
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 (12)
- UDI/DI 50885380182479(cs)
- 20885380182478(ea)
- Lot Numbers: N210278
- N210368
- N210423
- N210460
- N210468
- N210543
- N220050
- N220099
- N220139
- N220163
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 28 recalled by Cardinal Health 200, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 28 products in this recall →Related recalls
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