The Recall Desk
HighFDA (Devices)·Z-0968-2023·Announced 2023-01-25

Cardinal Health Jackson-Pratt Channel Drains recalled for performance defects

Cardinal Health is recalling 4,111 Jackson-Pratt Channel Drains (10 Fr) due to multiple performance issues including dull trocars, broken tips, reduced flexibility, and lack of radiopacity that may affect device function.

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 Class II recall of a surgical device with identified performance defects (broken tips, dull trocars, reduced flexibility, lack of radiopacity) that represent a risk of harm. No reported illnesses or injuries have been documented, meeting the criterion for High severity as a risk-of-harm product 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-2187). The recall affects 4,111 devices distributed worldwide, including the United States, Canada, Saudi Arabia, Singapore, and Hong Kong. Affected lot numbers are N210278, N210368, N210423, N210460, N210468, N210469, N210543, N220050, N220099, N220139, and N220163.

Cardinal Health received multiple complaints regarding performance issues with the drains. The identified defects include lack of radiopacity in the wound drain material, dull trocars that may not function as intended, reduced flexibility of the wound drain, and broken wound tips. These issues may impact the device's intended performance during surgical placement and use.

Healthcare institutions and medical professionals who have received affected drains should verify their inventory against the recalled lot numbers. Any affected devices should be managed according to Cardinal Health's recall instructions and applicable medical device regulations.

The recalled product

Product
Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2187
Manufacturer
Cardinal Health 200, LLC
Category
Medical Device — Surgical drain
Hazard
Affected units
4,111

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 50885380182424(cs)
  • 20885380182423(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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Same hazard · broken tip

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