The Recall Desk
HighFDA (Devices)·Z-0983-2023·Announced 2023-01-25

Cardinal Health Jackson-Pratt Channel Drain Recalled for Performance Defects

Cardinal Health is recalling Jackson-Pratt Channel Drains (19 Fr, REF JP-2225) due to multiple performance issues including lack of radiopacity, dull trocars, reduced flexibility, and broken wound tips. Approximately 4,112 units were distributed worldwide.

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 an FDA Class II recall of a surgical drainage device with multiple performance defects including broken tips and reduced flexibility, which represent a risk of harm in post-operative wound settings. No illnesses or injuries have been reported, placing this in the High severity category per the rubric.

Plain-English summary

Cardinal Health 200, LLC is recalling Cardinal Health Jackson-Pratt Channel Drains, 19 Fr (REF JP-2225), due to performance-related defects. The company has received multiple complaints regarding lack of radiopacity in wound drains, dull trocars that impact product performance, lack of flexibility of wound drains, and broken wound tips.

The affected units have UDI/DI codes 50885380182578 (case) and 20885380182577 (each), and include the following lot numbers: N210278, N210368, N210423, N210460, N210468, N210469, N210543, N220050, N220099, N220139, and N220163. A total of 4,112 units were distributed worldwide, including to the United States, Canada, Saudi Arabia, Singapore, and Hong Kong.

Healthcare providers and facilities that received affected drains should verify their inventory using the UDI and lot numbers provided. Providers should contact Cardinal Health for instructions regarding return, replacement, or other remediation options.

The recalled product

Product
Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2225
Manufacturer
Cardinal Health 200, LLC
Category
Medical Device — Surgical Drain
Hazard
Affected units
4,112

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 50885380182578(cs)
  • 20885380182577(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 →

Related recalls

Same manufacturer · Cardinal Health 200, LLC

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