Agency classClass IIOur severity:High FDA (Devices)·Z-0985-2023·Announced 2023-01-25

Jackson-Pratt Channel Drains Recalled for Multiple Performance Defects

Cardinal Health is recalling Jackson-Pratt Channel Drains due to performance defects including lack of radiopacity, dull trocars, reduced flexibility, and broken tips. The recall affects 7,129 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: FDA Class II recall for functional defects affecting critical device operations—imaging radiopacity, trocar sharpness, material flexibility, and tip integrity. No illnesses, injuries, or deaths are reported in the source, classifying these as theoretical risk-of-harm hazards.

Plain-English summary

Cardinal Health 200, LLC is recalling Jackson-Pratt Channel Drains (10 Fr, REF JP-2227) due to multiple performance defects identified through customer complaints. Approximately 7,129 units have been distributed worldwide to the United States, Canada, Saudi Arabia, Singapore, and Hong Kong.

The defects include lack of radiopacity (reduced visibility on imaging), dull trocars that impair insertion performance, reduced flexibility of the drain material, and broken wound tips. These issues may compromise the drain's intended function in wound management procedures.

Healthcare facilities should immediately cease use of affected lot numbers: N210278, N210368, N210423, N210460, N210468, N210469, N210543, N220050, N220099, N220139, and N220163. Patients who have had these drains implanted should contact their healthcare provider with any concerns about potential complications.

The recalled product

Product: Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2227
Manufacturer: Cardinal Health 200, LLC
Category: Medical Device — Surgical Drain
Hazard: radiopacity-defect
dull-trocar
flexibility-defect
broken-tip
Affected units: 7,129

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 50885380182592(cs)
20885380182591(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