FDA recall Z-0531-2022

Product

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.

Key facts

Status

Terminated

Initiation date

2021-12-22

Report date

2022-02-02

Termination date

2023-07-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

Brighton, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0531-2022