BioTex Reusable Adapter Kit recall
BioTex Reusable Adapter Kit, Part Number 401-021-1010, packaged non-sterile in a dedicated case for steam sterilization The Adapter Kit is used during…
Why was BioTex Reusable Adapter Kit recalled?
Medtronic Navigation is recalling the Biotex Adapter Kit because it was commercially distributed by BioTex without a cleared premarket [510(k)] from FDA.
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?
The adapter kits are not identified with any lot/code numbers. The BioTex Adapter kits were manufactured between 2008 and 2010.
- Product
- BioTex Reusable Adapter Kit, Part Number 401-021-1010, packaged non-sterile in a dedicated case for steam sterilization The Adapter Kit is used during…
- Recalling firm
- Medtronic Navigation, Inc.
- Quantity
- 4
- Distribution
- US Distribution to states of: FL, NJ, AZ, and NC.
- Recall date
- March 30, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)