Z-0531-2022 Class II Terminated
FDA device recall Z-0531-2022 was initiated by FlexDex Inc. on December 22, 2021 and is designated Class II. Reason for recall: 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… The recall status is terminated (terminated July 25, 2023). Affected quantity: 273.
Recall Details
- Product Type
- Devices
- Report Date
- February 2, 2022
- Initiation Date
- December 22, 2021
- Termination Date
- July 25, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 273
Product Description
8mm FlexDex Needle Driver, Product Code FD-335 ND
Reason for Recall
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.
Code Information
All lots