The Recall Desk
HighFDA (Devices)·Z-0991-2023·Announced 2023-01-25

Cardinal Health Jackson-Pratt Surgical Drains Recalled for Performance Defects

Cardinal Health is recalling 1920 Jackson-Pratt Channel Drains (15 Fr, model JP-2233) distributed worldwide due to multiple reported performance issues including lack of radiopacity, dull trocars, reduced flexibility, and broken wound tips.

What this means for you

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 with multiple reported performance defects affecting a critical surgical device used in wound care. Classification fits the rubric category 'risk-of-harm products where injury has not yet been reported'—no illnesses or injuries are documented in the source.

Plain-English summary

Cardinal Health 200, LLC is recalling 1920 Jackson-Pratt Channel Drains, 15 Fr (REF JP-2233) due to reported performance defects. The affected lot numbers are N210278, N210368, N210423, N210460, N210468, N210543, N220050, N220099, N220139, and N220163. Cardinal Health has received multiple complaints regarding these drains.

The reported defects include lack of radiopacity (preventing visualization on X-rays), dull trocars that impair insertion performance, reduced flexibility of the wound drainage tubes, and broken wound tips. These issues may compromise the proper functioning of the drainage system.

The affected drains were distributed worldwide, including throughout the United States and to Canada, Saudi Arabia, Singapore, and Hong Kong. This is an FDA Class II recall.

The recalled product

Product
Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2233
Manufacturer
Cardinal Health 200, LLC
Hazard
  • device-malfunction
  • radiopacity-defect
  • trocar-defect
  • broken-tip
  • flexibility-defect

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 (12)

  • UDI/DI 50885380182653(cs)
  • 20885380182652(ea)
  • Lot Numbers: N210278
  • N210368
  • N210423
  • N210460
  • N210468
  • N210543
  • N220050
  • N220099
  • N220139
  • N220163

Distribution

Distributed nationwide across the United States.