Z-0992-2023 Class II Ongoing
FDA device recall Z-0992-2023 was initiated by Cardinal Health 200, LLC on Dec 14, 2022 and is designated Class II. Reason for recall: 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… The recall status is ongoing. Affected quantity: 22847 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jan 25, 2023
- Initiation Date
- Dec 14, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 22847 units
Product Description
Cardinal Health Jackson-Pratt Channel Drain, 24 Fr, REF JP-2234
Reason for Recall
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.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia, Singapore, Hong Kong.
Code Information
UDI/DI 50885380182660(cs), 20885380182669(ea), Lot Numbers: N210278, N210347, N210368, N210423, N210460, N210468, N210469, N210543, N220050, N220099, N220139, N220163
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0992-2023
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026