Z-0820-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- February 7, 2024
- Initiation Date
- November 29, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 804 units
Product Description
Custom procedural convenience kits and trays, ear, nose & throat, labeled as: a) T AND A PACK AGH ASC, kit number AGTA48J; b) OPSC EAR PACK, kit number LLEO66; c) T AND A PACK, kit number MMTA41F
Reason for Recall
During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting documentation stating the "piggybacked" components were assessed to determine if they were suitable for exposure to elevated temperatures for an extended period of time and further exposure to sterilization. As a result, the piggybacked components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) may have had higher than specified EO residuals.
Distribution Pattern
US Nationwide distribution.
Code Information
a) AGTA48J, UDI/DI 00191072142870, lot numbers: 890231, exp. 45402; 920231, exp. 45372; 941231, exp. 45350; 976231, exp. 45315; 645221, exp. 45281; 659221, exp. 45267; 686221, exp. 45240; 755221, exp. 45171; 836221, exp. 45090; b) LLEO66, UDI/DI 00191072165541, lot numbers: 813221, exp. 7/6/2023; 763221, exp. 8/25/2023; 696221, exp. 10/31/2023; 984231, exp. 1/16/2024; 905231, exp. 4/5/2024; c) MMTA41F, UDI/DI none, lot numbers: 899231, exp. 4/11/2024