American Contract Systems, Inc. Recall 93086
Description: Robotics Pack SAH, REF SAR530M
American Contract Systems, Inc. Recall 93086 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0174-2024 |
| Event ID | 93086 |
| Event Description | Robotics Pack SAH, REF SAR530M |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of FL, IA. |
| Quantity | 96 cases |
| Recall Reason | During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and Adhesive Dermabond (part number DHVM12) were inadvertently subjected to the ACS sterilization process and exposed to EO and higher temperatures than approved by the component manufacturer. As a result, the components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) have higher than specified EO residuals. |
| Device Classification | 20231101 |
| Device Code Info | UDI/DI00191072179678, Lot Numbers: 949231, 983231 |
| Center Classification Date | 20231026 |
| Recall Initiation Date | 20230901 |
| Recalling Firm | American Contract Systems, Inc. |
| Initial Notification | |
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