Device product
Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2214
Z-0977-2023
Product summary
- Event
- Event 91322
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3550 units
- Official record key
device-enforcement:Z-0977-2023
Official wording
Reason: Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of flexibility of wound drains, and broken wound tips.
Code information: UDI/DI 50885380182516(cs), 20885380182515(ea), Lot Numbers: N210278, N210347, N210368, N210423, N210460, N210468, N210469, N210543, N220050, N220099, N220139, N220163
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia, Singapore, Hong Kong.
Derived failure modes
-
Unknown
Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of flexibility of wound drains, and broken wound tips.