Agency classClass IIOur severity:High FDA (Devices)·Z-0977-2023·Announced 2023-01-25

Cardinal Health Jackson-Pratt Channel Drain Recalled for Performance Defects

Cardinal Health is recalling Jackson-Pratt Channel Drains (10 mm) due to performance issues including lack of radiopacity, dull trocars, reduced flexibility, and broken wound tips that may impair drain function.

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 involving risk-of-harm performance defects in a surgical device used in post-operative care. No illnesses or injuries have been reported in the source text, limiting the classification to High rather than Severe.

Plain-English summary

Cardinal Health 200, LLC is recalling 3,550 units of the Jackson-Pratt Channel Drain, 10 mm (REF JP-2214) due to multiple performance defects identified during use.

The recalled drains exhibit the following issues: lack of radiopacity (making drains non-visible on X-rays), dull trocars that impair insertion performance, reduced flexibility that limits proper positioning, and broken wound tips that may fragment. These defects may prevent the drain from functioning properly during post-operative wound management.

The product was 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.

Customers possessing this product should discontinue use and contact Cardinal Health for instructions on device return or replacement.

The recalled product

Product: Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2214
Manufacturer: Cardinal Health 200, LLC
Category: Medical Device — Surgical Drain
Hazard: radiopacity-defect
trocar-defect
flexibility-defect
tip-breakage
Affected units: 3,550

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 50885380182516(cs)
20885380182515(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