Cardinal Health Jackson-Pratt Channel Drains recalled for performance defects
Cardinal Health is recalling Jackson-Pratt Channel Drains (7 mm, REF JP-2211) due to performance issues including lack of radiopacity, dull trocars, reduced flexibility, and broken tips. About 1,768 units 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: This is a Class II medical device recall with multiple performance defects in a surgical drain. No illnesses or injuries have been reported. However, defects affecting drain function (radiopacity, trocar performance, flexibility, and tip integrity) present a risk of harm to patients requiring proper wound drainage in post-surgical care.
Plain-English summary
Cardinal Health is recalling 1,768 Jackson-Pratt Channel Drains (7 mm, REF JP-2211) due to multiple performance defects. The recalled drains are manufactured by Cardinal Health 200, LLC and were distributed worldwide, including the United States, Canada, Saudi Arabia, Singapore, and Hong Kong.
The company received multiple complaints about performance issues with these drains: lack of radiopacity, dull trocars that impact product performance, reduced flexibility of the drains, and broken wound tips. These defects may impair proper device function during clinical use.
Healthcare facilities and patients who have these units should contact Cardinal Health 200, LLC for further instructions. The affected lot numbers are N210278, N210368, N210423, N210460, N210468, N210469, N210543, N220050, N220099, N220139, and N220163.
The recalled product
- Product
- Cardinal Health Jackson-Pratt Channel Drain, 7 mm, REF JP-2211
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Surgical Drain
- Affected units
- 1,768
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 50885380182486(cs)
- 20885380182485(ea)
- Lot Numbers: N210278
- N210368
- N210423
- N210460
- N210468
- N210469
- 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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