The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0980-2023·Announced 2023-01-25

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

Cardinal Health is recalling 750 units of Jackson-Pratt Channel Drains (10 mm) due to multiple performance issues including broken drain tips, lack of radiopacity, dull trocars, and reduced flexibility that could affect surgical outcomes.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 FDA recall of a surgical device with documented performance defects that could result in retained foreign material or inadequate wound drainage. Although no injuries or illnesses have been reported, the defects—particularly broken drain tips and lack of radiopacity—present a direct risk to patient safety, meeting the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Cardinal Health 200, LLC is recalling 750 units of the Jackson-Pratt Channel Drain, 10 mm (REF JP-2217). The recall affects products distributed worldwide, including in the United States, Canada, Saudi Arabia, Singapore, and Hong Kong.

The FDA-classified Class II recall was initiated after Cardinal Health received multiple complaints about performance defects in the drains. Issues reported include lack of radiopacity (visibility on X-ray), dull trocars affecting insertion performance, reduced flexibility of the drain material, and broken drain tips.

These defects could compromise the drain's intended function and patient safety. A broken drain tip could potentially remain in the wound and be difficult or impossible to locate via X-ray imaging due to the lack of radiopacity. Reduced flexibility or dull trocars may impact proper insertion and placement during surgery.

Healthcare providers and facilities should immediately stop using affected lots (N210278, N210347, N210368, N210423, N210460, N210468, N210469, N210543, N220050, N220099, N220139, N220163) and contact Cardinal Health for further instructions. Any patients believed to have been affected by these devices should consult with their healthcare provider.

The recalled product

Product
Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2217
Manufacturer
Cardinal Health 200, LLC
Category
Medical Device — Surgical Drain
Hazard
Affected units
750

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 50885380182547(cs)
  • 20885380182546(ea)
  • Lot Numbers: N210278
  • N210347
  • 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 →

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