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Recall Observatory FDA recall evidence

Device product

Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2223

Z-0982-2023

December 14, 2022

Class II

Product summary

Firm
Cardinal Health 200, LLC
Event
Event 91322
Status
Ongoing
Classification
Class II
Quantity
2259 units
Official record key
device-enforcement:Z-0982-2023

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 50885380182561(cs), 20885380182560(ea), Lot Numbers: N210278, N210368, N210423, N210460, N210468, 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

    reason.no_named_rule · v1.0.0

    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.