American Contract Systems, Inc. Recall 93656
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
American Contract Systems, Inc. Recall 93656 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0820-2024 |
| Event ID | 93656 |
| Event 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 |
| Product Type | Devices |
| Distribution | US Nationwide distribution. |
| Quantity | 804 units |
| Recall Reason | 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. |
| Device Classification | 20240207 |
| Device Code Info | 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 |
| Center Classification Date | 20240126 |
| Recall Initiation Date | 20231129 |
| Recalling Firm | American Contract Systems, Inc. |
| Initial Notification | |
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