FDA Recall
Terminated
8mm FlexDex Needle Driver, Product Code FD-335 ND
Recall: Z-0531-2022
·
Initiated December 22, 2021
Recall
- Recall Number
- Z-0531-2022
- Event Number
- 89316
- Firm
- FlexDex Inc.
- FEI Number
- 3012046682
- Product Code
- MDM
- Status
- Terminated
- Root Cause
- Unknown/Undetermined by firm
- Initiated
- December 22, 2021
- Terminated
- July 25, 2023
- Address
- 10421 Citation Dr, Ste 900, Brighton, MI, 48116-6558
Description
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.
Action
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.
Distribution
n/a
Quantity
273