Agency classClass IIOur severity:High FDA (Devices)·Z-0986-2023·Announced 2023-01-25

Cardinal Health Jackson-Pratt Drain Recalled for Performance Defects

Cardinal Health is recalling Jackson-Pratt Channel Drains (15 Fr, REF JP-2228) due to multiple performance issues including dull trocars, broken wound tips, lack of radiopacity, and inflexibility. The recall affects approximately 15,493 units 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 FDA Class II recall involves functional defects in a surgical device with direct patient contact. While no injuries or hospitalizations have been reported, the defects—dull trocars, broken tips, lack of radiopacity, and inflexibility—represent potential risk-of-harm in a device critical for post-operative care, warranting a High severity score.

Plain-English summary

Cardinal Health is recalling Jackson-Pratt Channel Drains (Model 15 Fr, REF JP-2228) used in post-surgical wound drainage. The recall covers approximately 15,493 units that were distributed worldwide, including the United States, Canada, Saudi Arabia, Singapore, and Hong Kong.

The drains are being recalled due to multiple performance issues identified in complaints received by Cardinal Health. These issues include lack of radiopacity (making drains difficult to locate via imaging), dull trocars that impact insertion performance, reduced flexibility of the drains, and broken wound tips.

Healthcare providers and facilities that received units with lot numbers N210278, N210368, N210423, N210460, N210468, N210469, N210543, N220050, N220099, N220139, and N220163 should stop using the affected drains and consult with Cardinal Health for further instructions. Patients who may have received this drain should contact their healthcare provider with any concerns.

The recalled product

Product: Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2228
Manufacturer: Cardinal Health 200, LLC
Category: Medical Device — Surgical Drain
Hazard: dull-trocar
broken-tip
lack-of-radiopacity
inflexibility
Affected units: 15,493

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 50885380182608(cs)
20885380182607(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 →

Same manufacturer · Cardinal Health 200, LLC

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Same hazard · dull trocar