Agency classClass IIOur severity:High FDA (Devices)·Z-0982-2023·Announced 2023-01-25

Jackson-Pratt Wound Drain Recalled for Performance Issues

Cardinal Health recalls Jackson-Pratt Channel Drains (15 Fr) due to performance issues: broken tips, dull trocars, lack of radiopacity, and reduced flexibility affecting surgical wound drainage.

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 involving multiple performance defects (broken tips, dull trocars, lack of radiopacity, reduced flexibility) affecting a surgical wound drain. No reported illnesses or injuries documented. This qualifies as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Cardinal Health 200, LLC is recalling Jackson-Pratt Channel Drains, 15 Fr (Reference JP-2223). The recall involves approximately 2,259 units distributed worldwide, including the United States, Canada, Saudi Arabia, Singapore, and Hong Kong.

The company received multiple complaints regarding performance issues with these drains, including lack of radiopacity (inability to be visualized on X-rays), dull trocars that impair insertion performance, reduced flexibility, and broken wound tips.

The recalled lot numbers are N210278, N210368, N210423, N210460, N210468, N210543, N220050, N220099, N220139, and N220163. This is a Class II recall issued by the FDA.

The recalled product

Product: Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2223
Manufacturer: Cardinal Health 200, LLC
Category: Medical Device — Surgical Drainage Device
Hazard: dull-trocar
broken-tip
lack-of-radiopacity
lack-of-flexibility
Affected units: 2,259

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 50885380182561(cs)
20885380182560(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 →

Same manufacturer · Cardinal Health 200, LLC

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Same hazard · dull trocar