American Contract Systems Inc Recall 96343
Description: MAJOR VASCULAR PACK , Model No UTMV78X-01 UTMV78Y UTMV78Y-01 UTMV78X-01 UTMV78Y-02
American Contract Systems Inc Recall 96343 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1358-2025 |
| Event ID | 96343 |
| Event Description | MAJOR VASCULAR PACK , Model No UTMV78X-01 UTMV78Y UTMV78Y-01 UTMV78X-01 UTMV78Y-02 |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the state of OH. |
| Quantity | 147 kits |
| Recall Reason | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment. |
| Device Classification | 20250326 |
| Device Code Info | UDI-DI 00191072205100 00191072217370 Lots 974241 884241 70-051159 70-052011 70-052602 70-053158 |
| Center Classification Date | 20250314 |
| Recall Initiation Date | 20250206 |
| Recalling Firm | American Contract Systems Inc |
| Initial Notification | |
| Similar To |