8mm FlexDex Needle Driver, Product Code FD-335 ND
FDA Recall #Z-0531-2022 — Class II — December 22, 2021
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.
Recalling Firm
FlexDex Inc. — Brighton, MI
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
273
Code Information
All lots
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated