The Recall Desk
HighFDA (Devices)·Z-0971-2023·Announced 2023-01-25

Cardinal Health Jackson-Pratt Channel Drains Recalled for Multiple Performance Defects

Cardinal Health is recalling 3,507 Jackson-Pratt Channel Drains (19 Fr) due to performance defects including lack of radiopacity, dull trocars, lack of flexibility, and broken tips. Drains 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: FDA Class II medical device with documented performance defects affecting surgical drain functionality in post-operative care. No illnesses or injuries reported, but the defects present risk of harm if the device fails to function properly during clinical use.

Plain-English summary

Cardinal Health is recalling Jackson-Pratt Channel Drains (19 Fr, REF JP-2190) due to multiple performance defects identified in the devices. The recall affects 3,507 units that were distributed worldwide, including the United States, Canada, Saudi Arabia, Singapore, and Hong Kong.

The recalled drains exhibit the following documented defects: lack of radiopacity, dull trocars that impact product performance, lack of flexibility, and broken wound tips. These issues may impair the drain's function in post-surgical wound management.

The affected lot numbers are N210278, N210347, N210368, N210423, N210460, N210468, N210469, N210543, N220099, N220050, N220139, and N220163. Entities that received these units should verify product lot numbers and take appropriate action based on their protocols.

The recalled product

Product
Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2190
Manufacturer
Cardinal Health 200, LLC
Category
Medical Device — Surgical Drain
Hazard
Affected units
3,507

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 (14)

  • UDI/DI 50885380182455(cs)
  • 20885380182454(ea)
  • Lot Numbers: N210278
  • N210347
  • N210368
  • N210423
  • N210460
  • N210468
  • N210469
  • N210543
  • N220099
  • N220050
  • 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

See all →

Same hazard · lack of radiopacity

See all →