Agency classClass IIOur severity:High FDA (Devices)·Z-0981-2023·Announced 2023-01-25

Cardinal Health Jackson-Pratt Channel Drains recalled for multiple performance defects

Cardinal Health is recalling Jackson-Pratt Channel Drains (10 Fr, REF JP-2221) due to multiple performance issues including broken wound tips, dull trocars, lack of radiopacity, and reduced flexibility affecting 179 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 of a surgical drain with multiple documented performance defects (broken tips, dull trocars, lack of radiopacity, reduced flexibility) that could impact proper wound drainage. No illnesses or injuries have been reported in the source text, fitting the 'risk-of-harm product without reported injury' category.

Plain-English summary

Cardinal Health 200, LLC is recalling Cardinal Health Jackson-Pratt Channel Drains, model 10 Fr, REF JP-2221. The recall affects 179 units that were distributed worldwide, including to the United States, Canada, Saudi Arabia, Singapore, and Hong Kong. Affected lot numbers are N210278, N210368, N210423, N210460, N210468, N210469, N210543, N220050, N220099, N220139, and N220163.

The recall was initiated after Cardinal Health received multiple complaints regarding performance issues with the drain, including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of flexibility of wound drains, and broken wound tips.

These drains are used as post-surgical wound drainage devices. Healthcare providers and patients who have used or received these drains from the affected lots should contact Cardinal Health for information regarding their devices and the recall.

The recalled product

Product: Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2221
Manufacturer: Cardinal Health 200, LLC
Category: Medical Device — Surgical Drain
Hazard: broken-tips
dull-trocars
lack-of-radiopacity
lack-of-flexibility
Affected units: 179

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 50885380182554(cs)
20885380182553(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 · broken tips