FlexDex Inc. recalls 8mm FlexDex Needle Driver, Product Code FD-335 ND

Recall date

December 22, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0531-2022

FDA classification

Class II

Brand / firm

FlexDex Inc.

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

8mm FlexDex Needle Driver, Product Code FD-335 ND