8mm FlexDex Needle Driver recall
8mm FlexDex Needle Driver, Product Code FD-335 ND
Why was 8mm FlexDex Needle Driver 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All lots
- Product
- 8mm FlexDex Needle Driver, Product Code FD-335 ND
- Recalling firm
- FlexDex Inc.
- Quantity
- 273
- Recall date
- February 2, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)