Agency classClass IIOur severity:High FDA (Devices)·Z-0987-2023·Announced 2023-01-25

Cardinal Health surgical drain recalled for performance and safety defects

Cardinal Health is recalling approximately 24,963 Jackson-Pratt Channel Drains due to multiple performance defects including broken tips, dull insertion tools, reduced flexibility, and visibility issues. 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 affecting a surgical medical device with structural and performance defects (broken tips, dull trocars, reduced flexibility, lack of radiopacity) that could compromise device function. No illnesses or injuries have been reported in the source text. Per the rubric, risk-of-harm products where injury has not yet been reported score 3.

Plain-English summary

Cardinal Health 200, LLC is recalling its Jackson-Pratt Channel Drain (15 Fr, Model JP-2229) due to multiple performance defects. Approximately 24,963 units were distributed worldwide, including the United States, Canada, Saudi Arabia, Singapore, and Hong Kong.

The affected drains have reported defects including: lack of radiopacity (reduced visibility on X-ray), dull insertion trocars affecting device performance, reduced flexibility of the drain material, and broken wound tips. These defects may compromise the device's function during post-operative drainage.

Affected lot numbers are: N210278, N210347, N210368, N210423, N210460, N210468, N210469, N210543, N220050, N220099, N220139, and N220163. Healthcare facilities should identify and cease using affected units. Contact the manufacturer or distributor for replacement or return information.

Patients and healthcare providers should monitor for any complications related to the affected drains and report any adverse events to the FDA's MedWatch program.

The recalled product

Product: Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2229
Manufacturer: Cardinal Health 200, LLC
Category: Medical Device — Surgical / Drainage
Hazard: broken-tips
dull-trocar
insufficient-flexibility
radiopacity-deficiency
Affected units: 24,963

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 50885380182615(cs)
20885380182614(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