Reported Feb 2, 2022 · Terminated
8mm FlexDex Needle Driver, Product Code FD-335 ND
FlexDex Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: FlexDex Inc. · 10421 Citation Dr Ste 900 · Brighton, MI · 48116-6558
Is this the product you have?
8mm FlexDex Needle DriverProduct Code FD-335 ND
- Lot codes and dates
- All lots
- Amount recalled
- 273
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.
This product could cause temporary or reversible health problems — stop using it.
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