Recall Z-0902-2022
Cardinal Health 200, LLC · initiated March 15, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Cardinal Health PROTEXIS PI and PI Classic, Surgical Gloves
Codes / lots: 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
Reason for recall
Product was distributed without being sterilized.
FDA-determined 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.
Details
- Recall number
- Z-0902-2022
- Initiated
- March 15, 2022
- Product code
- KGO – Surgeon'S Gloves
- Quantity
- 486,578 pairs
- Distribution
- Product distributed throughout United States and Guam
- Recalling firm
- Cardinal Health 200, LLC, Waukegan, IL