Cardinal Health Jackson-Pratt Channel Drains Recalled for Multiple Performance Defects
Cardinal Health is recalling 3,507 Jackson-Pratt Channel Drains (19 Fr) due to performance defects including lack of radiopacity, dull trocars, lack of flexibility, and broken tips. Drains were distributed worldwide.
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 documented performance defects affecting surgical drain functionality in post-operative care. No illnesses or injuries reported, but the defects present risk of harm if the device fails to function properly during clinical use.
Plain-English summary
Cardinal Health is recalling Jackson-Pratt Channel Drains (19 Fr, REF JP-2190) due to multiple performance defects identified in the devices. The recall affects 3,507 units that were distributed worldwide, including the United States, Canada, Saudi Arabia, Singapore, and Hong Kong.
The recalled drains exhibit the following documented defects: lack of radiopacity, dull trocars that impact product performance, lack of flexibility, and broken wound tips. These issues may impair the drain's function in post-surgical wound management.
The affected lot numbers are N210278, N210347, N210368, N210423, N210460, N210468, N210469, N210543, N220099, N220050, N220139, and N220163. Entities that received these units should verify product lot numbers and take appropriate action based on their protocols.
The recalled product
- Product
- Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2190
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Surgical Drain
- Affected units
- 3,507
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 50885380182455(cs)
- 20885380182454(ea)
- Lot Numbers: N210278
- N210347
- N210368
- N210423
- N210460
- N210468
- N210469
- N210543
- N220099
- N220050
- 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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