8mm FlexDex Needle Driver, Product Code FD-335 ND
Reported: February 2, 2022 Initiated: December 22, 2021 #Z-0531-2022
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.
Details
- Recalling Firm
- FlexDex Inc.
- Units Affected
- 273
- Location
- Brighton, MI
Frequently Asked Questions
What product was recalled? ▼
8mm FlexDex Needle Driver, Product Code FD-335 ND. Recalled by FlexDex Inc.. Units affected: 273.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 2, 2022. Severity: Moderate. Recall number: Z-0531-2022.
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