Cardinal Health Jackson-Pratt Wound Drain Recall Due to Performance Defects
Cardinal Health is recalling Jackson-Pratt Channel Drains due to performance issues including lack of radiopacity, dull trocars, reduced flexibility, and broken tips. The worldwide recall affects units used in post-operative wound drainage.
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 FDA recall of a surgical device with reported functional defects that could compromise its intended use in post-operative wound drainage. Although no injuries or illnesses have been reported, the performance defects constitute a risk-of-harm scenario meeting the rubric criterion for High severity.
Plain-English summary
Cardinal Health is recalling Jackson-Pratt Channel Drains, 28 Fr (REF JP-2290) manufactured by Cardinal Health 200, LLC. The recall affects 5,680 units distributed worldwide, including the United States, Canada, Saudi Arabia, Singapore, and Hong Kong. The affected lot numbers are N210278, N210347, N210368, N210423, N210460, N210468, N210469, N210543, N220050, N220099, N220139, and N220163.
Cardinal Health has received multiple complaints regarding performance issues with these wound drains. Reported defects include lack of radiopacity (inability to visualize the drain on imaging), dull trocars that impair product performance, reduced flexibility of the drain, and broken wound tips.
Healthcare facilities and providers using these drains should check their inventory against the lot numbers listed and discontinue use of affected units. Facilities should review their patient records to identify any patients who received drains from the recalled lots and take appropriate clinical action based on their individual cases.
The recalled product
- Product
- Cardinal Health Jackson-Pratt Channel Drain, 28 Fr, REF JP-2290
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Surgical Drain
- Hazard
- lack-of-radiopacity
- dull-trocar
- lack-of-flexibility
- broken-trocar-tip
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 50885380182677(cs)
- 20885380182676(ea)
- Lot Numbers: N210278
- N210347
- N210368
- N210423
- N210460
- N210468
- N210469
- N210543
- N220050
- N220099
- N220139
- N220163
Distribution
Distributed nationwide across the United States.
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