Recall Z-0531-2022
FlexDex Inc. · initiated December 22, 2021
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
8mm FlexDex Needle Driver, Product Code FD-335 ND
Codes / lots: All lots
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.
FDA-determined cause: Unknown/Undetermined by firm
Action taken
The firm sent a letter to customers reiterating the IFU's statement "Do not use if package is damaged." This is important to ensure the sterility of the product. If upon inspection of the packaging, any damage is observed, including pinholes or tears in the pouch, the product should not be used. Please forward this letter on to all those who need to be aware within your organization and to any other organizations (e.g. customers) on which this has an impact.
Details
- Recall number
- Z-0531-2022
- Initiated
- December 22, 2021
- Terminated
- July 25, 2023
- Product code
- MDM – Instrument, Manual, Surgical, General Use
- Quantity
- 273
- Distribution
- n/a
- Recalling firm
- FlexDex Inc., Brighton, MI