Agency classClass IIOur severity:High FDA (Devices)·Z-0967-2023·Announced 2023-01-25

Cardinal Health Jackson-Pratt Channel Drains Recalled for Performance Defects

Cardinal Health is recalling 1,150 Jackson-Pratt Channel Drains due to multiple performance defects including lack of radiopacity, dull trocars, reduced flexibility, and broken tips affecting post-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 with identified performance defects in a surgical wound drain but no reported illnesses, injuries, or deaths. The device defects represent a risk of harm to patients undergoing post-surgical wound management, meeting criteria for High severity.

Plain-English summary

Cardinal Health 200, LLC is recalling 1,150 Jackson-Pratt Channel Drains (10 Fr, REF JP-2186) due to multiple performance defects. The recalled devices have lot numbers N210278, N210368, N210423, N210460, N210468, N210469, N210543, N220050, N220099, N220139, and N220163.

The drains were identified as having several performance issues: lack of radiopacity (visibility on X-ray imaging), dull trocars that impact insertion performance, reduced flexibility, and broken wound tips. These defects can affect the device's ability to provide proper post-surgical wound drainage.

The affected devices were distributed worldwide, including to the United States, Canada, Saudi Arabia, Singapore, and Hong Kong. Hospitals and healthcare facilities that have stocked these drains should verify their inventory against the provided lot numbers.

The recalled product

Product: Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2186
Manufacturer: Cardinal Health 200, LLC
Category: Medical Device — Surgical Drain
Hazard: radiopacity-defect
trocar-defect
flexibility-defect
tip-defect
Affected units: 1,150

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 50885380182417(cs)
20885380182416(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 · radiopacity defect