The Recall Desk
HighFDA (Devices)·Z-0974-2023·Announced 2023-01-25

Cardinal Health Jackson-Pratt Channel Drains recalled for performance defects

Cardinal Health is recalling Jackson-Pratt Channel Drains (7 mm, REF JP-2211) due to performance issues including lack of radiopacity, dull trocars, reduced flexibility, and broken tips. About 1,768 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 a Class II medical device recall with multiple performance defects in a surgical drain. No illnesses or injuries have been reported. However, defects affecting drain function (radiopacity, trocar performance, flexibility, and tip integrity) present a risk of harm to patients requiring proper wound drainage in post-surgical care.

Plain-English summary

Cardinal Health is recalling 1,768 Jackson-Pratt Channel Drains (7 mm, REF JP-2211) due to multiple performance defects. The recalled drains are manufactured by Cardinal Health 200, LLC and were distributed worldwide, including the United States, Canada, Saudi Arabia, Singapore, and Hong Kong.

The company received multiple complaints about performance issues with these drains: lack of radiopacity, dull trocars that impact product performance, reduced flexibility of the drains, and broken wound tips. These defects may impair proper device function during clinical use.

Healthcare facilities and patients who have these units should contact Cardinal Health 200, LLC for further instructions. The affected lot numbers are N210278, N210368, N210423, N210460, N210468, N210469, N210543, N220050, N220099, N220139, and N220163.

The recalled product

Product
Cardinal Health Jackson-Pratt Channel Drain, 7 mm, REF JP-2211
Manufacturer
Cardinal Health 200, LLC
Category
Medical Device — Surgical Drain
Hazard
Affected units
1,768

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 50885380182486(cs)
  • 20885380182485(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 · radiopacity defect

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