FlexDex Inc. Recall 89316
Description: 8mm FlexDex Needle Driver, Product Code FD-335 ND
FlexDex Inc. Recall 89316 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0531-2022 |
| Event ID | 89316 |
| Event Description | 8mm FlexDex Needle Driver, Product Code FD-335 ND |
| Product Type | Devices |
| Quantity | 273 |
| Recall Reason | The firm is reinforcing the IFU instructions: "Do not use if the package is damaged." If upon inspection of the packaging, any damage is observed, including pinholes or tears in the pouch, the product should not be used. |
| Device Classification | 20220202 |
| Device Code Info | All lots |
| Center Classification Date | 20220127 |
| Recall Initiation Date | 20211222 |
| Recalling Firm | FlexDex Inc. |
| Initial Notification | Letter |
| Similar To |