The DIXI Medical Microdeep Depth Electrode recall: Sterility Concern
The DIXI Medical Microdeep Depth Electrode ( Microdeep Depth Electrode or Electrode ) is a smooth electrode that is 0.8 mm in diameter with a…
Why was The DIXI Medical Microdeep Depth Electrode recalled?
Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag
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 UDI: 03664539000077
- Product
- The DIXI Medical Microdeep Depth Electrode ( Microdeep Depth Electrode or Electrode ) is a smooth electrode that is 0.8 mm in diameter with a…
- Recalling firm
- DIXI MEDICAL USA
- Quantity
- 2720 units
- Distribution
- US Nationwide distribution.
- Recall date
- February 9, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)