The Recall Desk
HighFDA (Devices)·Z-0982-2023·Announced 2023-01-25

Jackson-Pratt Wound Drain Recalled for Performance Issues

Cardinal Health recalls Jackson-Pratt Channel Drains (15 Fr) due to performance issues: broken tips, dull trocars, lack of radiopacity, and reduced flexibility affecting surgical wound drainage.

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 recall involving multiple performance defects (broken tips, dull trocars, lack of radiopacity, reduced flexibility) affecting a surgical wound drain. No reported illnesses or injuries documented. This qualifies as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Cardinal Health 200, LLC is recalling Jackson-Pratt Channel Drains, 15 Fr (Reference JP-2223). The recall involves approximately 2,259 units distributed worldwide, including the United States, Canada, Saudi Arabia, Singapore, and Hong Kong.

The company received multiple complaints regarding performance issues with these drains, including lack of radiopacity (inability to be visualized on X-rays), dull trocars that impair insertion performance, reduced flexibility, and broken wound tips.

The recalled lot numbers are N210278, N210368, N210423, N210460, N210468, N210543, N220050, N220099, N220139, and N220163. This is a Class II recall issued by the FDA.

The recalled product

Product
Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2223
Manufacturer
Cardinal Health 200, LLC
Hazard
  • dull-trocar
  • broken-tip
  • lack-of-radiopacity
  • lack-of-flexibility

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 50885380182561(cs)
  • 20885380182560(ea)
  • Lot Numbers: N210278
  • N210368
  • N210423
  • N210460
  • N210468
  • N210543
  • N220050
  • N220099
  • N220139
  • N220163

Distribution

Distributed nationwide across the United States.