Z-0902-2022 Class II
FDA device recall Z-0902-2022 was initiated by Cardinal Health 200, LLC on Mar 15, 2022 and is designated Class II. Reason for recall: Product was distributed without being sterilized. Affected quantity: 486,578 pairs.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 20, 2022
- Initiation Date
- Mar 15, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 486,578 pairs
Product Description
Cardinal Health PROTEXIS PI and PI Classic, Surgical Gloves
Reason for Recall
Product was distributed without being sterilized.
Distribution Pattern
Product distributed throughout United States and Guam
Code Information
Catalog Numbers: 1) 2D72PL65X, Lot Number TS21050195, EXP 04/30/2024 - UDI on ship case: 50885380031760; UDI on Dispenser carton: 20885380031769; UDI on individual unit: 10885380031762 2) 2D72PT65X, Lot Number TS21050215, EXP 04/30/2024 - UDI on ship case: 50885380031937, UDI on Dispenser carton: 20885380031936; UDI on individual unit: 10885380031939
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0902-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026