Agency classClass IIOur severity:High FDA (Devices)·Z-0989-2023·Announced 2023-01-25

Cardinal Health Jackson-Pratt Channel Drain recall for performance defects

Cardinal Health is recalling Jackson-Pratt Channel Drains due to performance defects: dull trocars, broken tips, lack of flexibility, and radiopacity issues. The 8,563 affected 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: FDA Class II medical device recall with documented structural defects that could impair function. No reported illnesses or injuries in the source material. This qualifies as a risk-of-harm product where injury has not yet been reported, meeting the Score 3 (High) criterion.

Plain-English summary

Cardinal Health 200, LLC is recalling the Jackson-Pratt Channel Drain, 19 Fr, model REF JP-2231, a surgical device used for wound drainage following surgical procedures. The recall affects approximately 8,563 units that were distributed worldwide, including the United States, Canada, Saudi Arabia, Singapore, and Hong Kong.

Cardinal Health received multiple complaints regarding performance issues with the affected drains. The identified issues include lack of radiopacity in the wound drain (meaning the drain cannot be clearly visualized on X-rays), dull trocars that may impact insertion, lack of flexibility in the drain tubing, and broken wound tips. These defects may affect the device's intended function and performance.

Healthcare facilities and individuals using or storing these drains should stop use and contact Cardinal Health for guidance on replacement or return procedures. The affected lot numbers are: N210278, N210347, N210368, N210423, N210460, N210468, N210469, N210543, N220050, N220099, N220139, and N220163. For complete information about this recall, consult the FDA's notice using the recall reference number Z-0989-2023.

The recalled product

Product: Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2231
Manufacturer: Cardinal Health 200, LLC
Category: Medical Device — Surgical Drain
Hazard: broken-tips
dull-trocars
lack-of-flexibility
lack-of-radiopacity
Affected units: 8,563

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 50885380182639(cs)
20885380182638(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 · broken tips