Recall Z-0531-2022— FlexDex Inc.

Name: FDA recall Z-0531-2022
Creator: U.S. Food and Drug Administration
Published: 2021-12-22

Class II · Terminated

Class II FDA medical device recall by FlexDex Inc., initiated 2021-12-22, terminated 2023-07-25. FDA's recall record names no specific 510(k) clearance for this event. Product: 8mm FlexDex Needle Driver, Product Code FD-335 ND. 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..

Recalling firm: FlexDex Inc.
Classification: Class II
Status: Terminated
Initiated: 2021-12-22
Terminated: 2023-07-25
Firm location: Brighton, MI, United States

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.