The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0984-2023·Announced 2023-01-25

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

Cardinal Health is recalling 2,277 Jackson-Pratt Channel Drains due to performance issues including lack of radiopacity, dull trocars, reduced flexibility, and broken tips. These defects may affect the drain's function and clinical performance.

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 device with multiple reported performance defects including radiopacity loss and component failures. While no injuries have been reported, these defects pose a risk to proper wound drainage and device function, meeting the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Cardinal Health 200, LLC is recalling the Jackson-Pratt Channel Drain, 10 Fr (REF JP-2226), a surgical wound drainage device. Approximately 2,277 units with lot numbers N210278, N210368, N210423, N210460, N210468, N210469, N210543, N220050, N220099, N220139, and N220163 have been distributed worldwide, including to the United States, Canada, Saudi Arabia, Singapore, and Hong Kong.

Cardinal Health received multiple complaints regarding performance issues with these drains. The reported defects include lack of radiopacity (inability to be visible on X-ray imaging), dull trocars affecting product performance, lack of flexibility in the drain material, and broken wound tips. These issues may compromise proper device function in wound care applications.

This recall is classified as FDA Class II. Healthcare facilities with inventory of affected products may contact Cardinal Health for guidance on return or replacement options.

The recalled product

Product
Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2226
Manufacturer
Cardinal Health 200, LLC
Category
Medical Device — Surgical / Wound Care
Hazard
Affected units
2,277

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 50885380182585(cs)
  • 20885380182584(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 →

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