Cardinal Health PROTEXIS PI and PI Classic, Surgical Gloves
This recall has been completed (originally issued March 15, 2022).
- Company
- Cardinal Health 200, Llc
- Recall Initiated
- March 15, 2022
- Recall Number
- Z-0902-2022
- Quantity
- 486,578 pairs
- Firm Location
- Waukegan, IL
- Official Source
- View on FDA website ↗
Reason for Recall
Product was distributed without being sterilized.
Distribution
Product distributed throughout United States and Guam
Lot / Code Info
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
Root Cause
Under Investigation by firm
Action Taken
A recall letter dated 03/16/2022 was distributed to impacted consignees. The letter informs consignees that a portion of the distributed lots were distributed without undergoing sterilization. Customers should review their inventory for the impacted lots, segregate and quarantine all affected product, complete the acknowledgement form and return to Cardinal Health. Any customers who may have received further distributed product should be contacted and provided the recall information.