Cardinal Health Jackson-Pratt Surgical Drains Recalled for Performance Defects
Cardinal Health is recalling 1920 Jackson-Pratt Channel Drains (15 Fr, model JP-2233) distributed worldwide due to multiple reported performance issues including lack of radiopacity, dull trocars, reduced flexibility, and broken wound tips.
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 medical device with multiple reported performance defects affecting a critical surgical device used in wound care. Classification fits the rubric category 'risk-of-harm products where injury has not yet been reported'—no illnesses or injuries are documented in the source.
Plain-English summary
Cardinal Health 200, LLC is recalling 1920 Jackson-Pratt Channel Drains, 15 Fr (REF JP-2233) due to reported performance defects. The affected lot numbers are N210278, N210368, N210423, N210460, N210468, N210543, N220050, N220099, N220139, and N220163. Cardinal Health has received multiple complaints regarding these drains.
The reported defects include lack of radiopacity (preventing visualization on X-rays), dull trocars that impair insertion performance, reduced flexibility of the wound drainage tubes, and broken wound tips. These issues may compromise the proper functioning of the drainage system.
The affected drains were distributed worldwide, including throughout the United States and to Canada, Saudi Arabia, Singapore, and Hong Kong. This is an FDA Class II recall.
The recalled product
- Product
- Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2233
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Surgical Drain
- Affected units
- 1,920
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 50885380182653(cs)
- 20885380182652(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.
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