The Recall Desk
HighFDA (Devices)·Z-0972-2023·Announced 2023-01-25

Cardinal Health Jackson-Pratt Channel Drains recalled due to performance defects

Cardinal Health is recalling Jackson-Pratt Channel Drains (19 Fr, REF JP-2191) due to multiple performance issues including lack of radiopacity, dull trocars, reduced flexibility, and broken wound tips. Approximately 3,520 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 device with multiple functional defects that could prevent proper drainage or device verification. However, no reported illnesses, injuries, or hospitalizations are mentioned, limiting the score to 3 per the rubric criterion for risk-of-harm products without reported harm.

Plain-English summary

Cardinal Health 200, LLC is recalling Cardinal Health Jackson-Pratt Channel Drains (19 Fr, REF JP-2191) due to multiple complaints regarding performance defects. The recalled drains are identified by lot numbers N210278, N210347, N210368, N210423, N210460, N210468, N210469, N210543, N220050, N220099, N220139, and N220163.

The reported defects include lack of radiopacity (making it difficult to verify drain position on X-ray imaging), dull trocars that may impact proper insertion, insufficient flexibility for appropriate placement within the wound cavity, and broken wound tips. These performance issues could potentially compromise the device's ability to function as intended for post-operative wound drainage.

Approximately 3,520 units were distributed worldwide, including to locations in the United States, Canada, Saudi Arabia, Singapore, and Hong Kong. Healthcare facilities and patients who have received these drains should verify their inventory against the affected lot numbers and contact Cardinal Health for guidance regarding the affected units.

The recalled product

Product
Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2191
Manufacturer
Cardinal Health 200, LLC
Category
Medical Device — Surgical Drain
Hazard
  • radiopacity-defect
  • trocar-defect
  • flexibility-defect
  • wound-tip-breakage

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 50885380182462(cs)
  • 20885380182461(ea)
  • Lot Numbers: N210278
  • N210347
  • N210368
  • N210423
  • N210460
  • N210468
  • N210469
  • N210543
  • N220050
  • N220099
  • N220139
  • N220163

Distribution

Distributed nationwide across the United States.

Related recalls

Same category