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.
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 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
- broken-drain-tip
- radiopacity-defect
- dull-trocar
- product-defect
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.
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