Agency classClass IIOur severity:High FDA (Devices)·Z-0972-2023·Announced 2023-01-25

Cardinal Health Jackson-Pratt Channel Drains recalled due to performance defects

Cardinal Health is recalling Jackson-Pratt Channel Drains (19 Fr, REF JP-2191) due to multiple performance issues including lack of radiopacity, dull trocars, reduced flexibility, and broken wound tips. Approximately 3,520 units were 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: This is an FDA Class II recall of a surgical device with multiple functional defects that could prevent proper drainage or device verification. However, no reported illnesses, injuries, or hospitalizations are mentioned, limiting the score to 3 per the rubric criterion for risk-of-harm products without reported harm.

Plain-English summary

Cardinal Health 200, LLC is recalling Cardinal Health Jackson-Pratt Channel Drains (19 Fr, REF JP-2191) due to multiple complaints regarding performance defects. The recalled drains are identified by lot numbers N210278, N210347, N210368, N210423, N210460, N210468, N210469, N210543, N220050, N220099, N220139, and N220163.

The reported defects include lack of radiopacity (making it difficult to verify drain position on X-ray imaging), dull trocars that may impact proper insertion, insufficient flexibility for appropriate placement within the wound cavity, and broken wound tips. These performance issues could potentially compromise the device's ability to function as intended for post-operative wound drainage.

Approximately 3,520 units were distributed worldwide, including to locations in the United States, Canada, Saudi Arabia, Singapore, and Hong Kong. Healthcare facilities and patients who have received these drains should verify their inventory against the affected lot numbers and contact Cardinal Health for guidance regarding the affected units.

The recalled product

Product: Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2191
Manufacturer: Cardinal Health 200, LLC
Category: Medical Device — Surgical Drain
Hazard: radiopacity-defect
trocar-defect
flexibility-defect
wound-tip-breakage
Affected units: 3,520

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 50885380182462(cs)
20885380182461(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 · radiopacity defect