The Recall Desk
HighFDA (Devices)·Z-0994-2023·Announced 2023-01-25

Cardinal Health Jackson-Pratt Surgical Drains Recalled for Multiple Defects

Cardinal Health recalls Jackson-Pratt Channel Drains due to reported defects including non-visibility on imaging, dull insertion trocars, reduced flexibility, and broken drain 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: This is a risk-of-harm product (post-operative wound drainage device) with confirmed product defects including broken components and malfunction of insertion instruments. No injuries or illnesses have been reported. The defects affect critical post-operative wound management, warranting a High severity score.

Plain-English summary

Cardinal Health 200, LLC is recalling Cardinal Health Jackson-Pratt Channel Drain, 32 Fr (REF JP-2292) due to multiple reported performance defects that affect the device's functionality and safety.

The recalled devices have been reported to have lack of radiopacity (inability to visualize the drain on X-rays), dull trocars that impact insertion performance, reduced flexibility of the wound drain, and broken wound drain tips. These defects could compromise proper wound drainage and device performance post-operatively.

The affected devices were distributed worldwide, including to hospitals and surgical facilities in the United States, Canada, Saudi Arabia, Singapore, and Hong Kong. Affected lot numbers are N210543, N210460, N210468, N210469, N220050, N220099, N220139, and N220163.

Healthcare facilities and providers using these devices should discontinue use of affected lot numbers and consult with Cardinal Health regarding replacement or return options.

The recalled product

Product
Cardinal Health Jackson-Pratt Channel Drain, 32 Fr, REF JP-2292
Manufacturer
Cardinal Health 200, LLC
Hazard
  • inadequate-visualization
  • trocar-defect
  • flexibility-defect
  • component-failure

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 (10)

  • UDI/DI 50885380182684(cs)
  • 20885380182683(ea)
  • Lot Numbers: N210543
  • N210460
  • N210468
  • N210469
  • N220050
  • N220099
  • N220139
  • N220163

Distribution

Distributed nationwide across the United States.