Agency classClass IIOur severity:High FDA (Devices)·Z-0976-2023·Announced 2023-01-25

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

Cardinal Health Jackson-Pratt Channel Drains are recalled for performance defects including dull trocars, broken tips, lack of flexibility, and lack of radiopacity. 220 units are affected.

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 reported performance defects in a surgical drainage device. No illnesses, injuries, or hospitalizations have been reported, meeting the criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Cardinal Health Jackson-Pratt Channel Drain, 10 mm (REF JP-2213) is being recalled. The product is a surgical wound drainage device. A total of 220 units are affected.

The recall was initiated due to multiple performance issues with the device. Cardinal Health received complaints regarding lack of radiopacity in the wound drains, dull trocars that impact product performance, lack of flexibility of the wound drains, and broken wound tips.

The affected units have been distributed worldwide, including throughout the United States, Canada, Saudi Arabia, Singapore, and Hong Kong. The recalled lot numbers are N210278, N210368, N210423, N210460, N210468, N210469, N210543, N220050, N220099, N220139, and N220163.

Healthcare facilities and users should verify the lot numbers of Jackson-Pratt Channel Drains in their inventory and quarantine any affected units. For more information or questions, contact Cardinal Health or the FDA.

The recalled product

Product: Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2213
Manufacturer: Cardinal Health 200, LLC
Category: Medical Device — Surgical Drain
Hazard: dull-trocar
broken-tip
lack-of-flexibility
lack-of-radiopacity
Affected units: 220

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 50885380182509(cs)
20885380182508(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