Agency classClass IIOur severity:High FDA (Devices)·Z-0992-2023·Announced 2023-01-25

Cardinal Health Jackson-Pratt Channel Drains recalled for performance defects

Cardinal Health is recalling 22,847 units of Jackson-Pratt Channel Drains due to performance issues including dull trocars, broken tips, lack of flexibility, and lack of radiopacity.

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 an FDA Class II recall of a medical device used in post-surgical wound management. While no injuries or illnesses have been reported, the performance defects—including broken tips and lack of visibility on imaging—create risk of harm during surgical drainage procedures, meeting the criteria for High severity.

Plain-English summary

Cardinal Health 200, LLC is recalling the Jackson-Pratt Channel Drain, 24 Fr (REF JP-2234), a surgical wound drainage device. Approximately 22,847 units have been recalled.

The company has received multiple complaints regarding performance issues with the product, including: lack of radiopacity (making the drain invisible on X-rays), dull trocars that impair insertion, reduced flexibility of the drain material, and broken wound drain tips.

The affected drains were distributed worldwide, including throughout the United States, Canada, Saudi Arabia, Singapore, and Hong Kong. Affected lot numbers are: N210278, N210347, N210368, N210423, N210460, N210468, N210469, N210543, N220050, N220099, N220139, and N220163.

Healthcare facilities should inspect drains from these lot numbers and consult with Cardinal Health or their local healthcare regulatory authority regarding replacement or alternative products. Drains should not be used if performance issues are suspected.

The recalled product

Product: Cardinal Health Jackson-Pratt Channel Drain, 24 Fr, REF JP-2234
Manufacturer: Cardinal Health 200, LLC
Category: Medical Device — Surgical / Wound Care Drain
Hazard: product-malfunction
broken-components
lack-of-radiopacity
improper-insertion
Affected units: 22,847

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 50885380182660(cs)
20885380182669(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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