Agency classClass IIOur severity:High FDA (Devices)·Z-0993-2023·Announced 2023-01-25

Cardinal Health Jackson-Pratt Wound Drain Recall Due to Performance Defects

Cardinal Health is recalling Jackson-Pratt Channel Drains due to performance issues including lack of radiopacity, dull trocars, reduced flexibility, and broken tips. The worldwide recall affects units used in post-operative 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: This is a Class II FDA recall of a surgical device with reported functional defects that could compromise its intended use in post-operative wound drainage. Although no injuries or illnesses have been reported, the performance defects constitute a risk-of-harm scenario meeting the rubric criterion for High severity.

Plain-English summary

Cardinal Health is recalling Jackson-Pratt Channel Drains, 28 Fr (REF JP-2290) manufactured by Cardinal Health 200, LLC. The recall affects 5,680 units distributed worldwide, including the United States, Canada, Saudi Arabia, Singapore, and Hong Kong. The affected lot numbers are N210278, N210347, N210368, N210423, N210460, N210468, N210469, N210543, N220050, N220099, N220139, and N220163.

Cardinal Health has received multiple complaints regarding performance issues with these wound drains. Reported defects include lack of radiopacity (inability to visualize the drain on imaging), dull trocars that impair product performance, reduced flexibility of the drain, and broken wound tips.

Healthcare facilities and providers using these drains should check their inventory against the lot numbers listed and discontinue use of affected units. Facilities should review their patient records to identify any patients who received drains from the recalled lots and take appropriate clinical action based on their individual cases.

The recalled product

Product: Cardinal Health Jackson-Pratt Channel Drain, 28 Fr, REF JP-2290
Manufacturer: Cardinal Health 200, LLC
Category: Medical Device — Surgical Drain
Hazard: lack-of-radiopacity
dull-trocar
lack-of-flexibility
broken-trocar-tip
Affected units: 5,680

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 (14)

UDI/DI 50885380182677(cs)
20885380182676(ea)
Lot Numbers: N210278
N210347
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