The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0975-2023·Announced 2023-01-25

Cardinal Health Jackson-Pratt Channel Drain recalled for performance defects

Cardinal Health is recalling Jackson-Pratt Channel Drains (10 mm, model JP-2212) due to multiple performance defects including lack of radiopacity, dull trocars, reduced flexibility, and broken wound tips.

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 Class II FDA medical device recall involves performance defects that could impair proper surgical wound drainage. Although no illnesses or injuries have been reported, the product defects (broken tips, dull trocars, reduced flexibility, lack of radiopacity) create a risk of harm in post-surgical wound management, meeting the criterion for High severity (Score 3).

Plain-English summary

Cardinal Health 200, LLC is recalling Cardinal Health Jackson-Pratt Channel Drains, 10 mm (model JP-2212), distributed worldwide including the US, Canada, Saudi Arabia, Singapore, and Hong Kong. The recall affects approximately 892 units identified by specific lot numbers: N210278, N210368, N210423, N210460, N210468, N210469, N210543, N220050, N220099, N220139, and N220163.

The drains are being recalled due to multiple performance issues reported by customers. These include lack of radiopacity (reduced visibility on X-rays), dull trocars that may impact insertion and performance, reduced flexibility of the drain material, and broken wound tips. These defects may compromise the ability of the drain to function properly in post-surgical wound management.

Cardinal Health Jackson-Pratt Channel Drains are surgical wound drainage devices used after surgery to prevent fluid accumulation and infection. Healthcare facilities, surgeons, and patients who may have received this product should check the lot numbers listed above. If your facility has units from these lots, cease use immediately and contact Cardinal Health for replacement or instructions.

Patients who received these drains should contact their healthcare provider if they have concerns about their wound drainage or recovery. Anyone experiencing complications related to drain failure should report the incident to the FDA via the MedWatch program and to Cardinal Health.

The recalled product

Product
Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2212
Manufacturer
Cardinal Health 200, LLC
Category
Medical Device — Surgical Drain
Hazard
Affected units
892

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 50885380182493(cs)
  • 20885380182492(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 →

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