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 |
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