Agency classClass IIOur severity:High FDA (Devices)·Z-0978-2023·Announced 2023-01-25

Cardinal Health Jackson-Pratt Channel Drains Recalled for Multiple Performance Issues

Cardinal Health is recalling Jackson-Pratt Channel Drains due to performance issues including lack of radiopacity, dull trocars, reduced flexibility, and broken tips. No injuries have been reported.

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 Class II recall involves a surgical medical device with multiple documented performance defects (lack of radiopacity, dull trocars, reduced flexibility, broken tips) that could impair proper clinical function. However, no illnesses or injuries have been reported, placing it in the 'risk-of-harm products where injury has not yet been reported' category.

Plain-English summary

Cardinal Health 200, LLC is recalling Cardinal Health Jackson-Pratt Channel Drains (10 mm, REF JP-2215) worldwide. The recall affects 812 units distributed across the United States, Canada, Saudi Arabia, Singapore, and Hong Kong.

The company received multiple complaints regarding performance issues with the drains, including lack of radiopacity (visibility on imaging), dull trocars that impact insertion performance, reduced flexibility of the drain, and broken wound tips. These issues could potentially affect the proper placement and function of the drain during medical procedures.

Patients or healthcare providers who have received or used these drains should contact Cardinal Health with questions or to report any adverse events. 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, 10 mm, REF JP-2215
Manufacturer: Cardinal Health 200, LLC
Category: Medical Device — Surgical Drain
Hazard: lack-of-radiopacity
dull-trocar
lack-of-flexibility
broken-tips
Affected units: 812

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 50885380182523(cs)
20885380182522(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 · lack of radiopacity