Cardinal Health Jackson-Pratt Channel Drain: Multiple Performance Defects
Cardinal Health is recalling Jackson-Pratt Channel Drains due to multiple reported performance defects including dull trocars, lack of flexibility, missing radiopacity, and broken tips. These issues may compromise insertion and drain function.
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: FDA Class II recall for a surgical device with multiple reported performance defects affecting insertion safety and drain function. While no injuries have been reported, these defects represent risk-of-harm in a surgical application where proper insertion and function are critical to patient safety.
Plain-English summary
Cardinal Health is recalling Cardinal Health Jackson-Pratt Channel Drains (15 Fr, REF JP-2188) due to multiple reported performance defects. The affected drains, totaling 2,480 units with specific lot numbers, have exhibited lack of radiopacity (inability to visualize on X-ray), dull trocars that impact insertion, reduced flexibility, and broken wound tips.
The recalled drains were distributed worldwide, including across the United States, Canada, Saudi Arabia, Singapore, and Hong Kong. Healthcare facilities and patients who received these drains should verify their lot numbers against the recalled batches.
No injuries or illnesses have been reported to date. However, these performance defects may compromise proper drain placement and function following surgery. Affected healthcare providers and patients should contact Cardinal Health or consult their healthcare provider for guidance on replacement or management options.
The recalled product
- Product
- Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2188
- Manufacturer
- Cardinal Health 200, LLC
- Affected units
- 2,480
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 50885380182431(cs)
- 20885380182430(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.
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