Official recall notice
FDA DeviceClass IINotable
FDA Recall: eTRAX Needle System Starter Kit 12G (for Aurora Trackers), Part Number 667-149
- Recall date
- 2026-04-08
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
Recommended action
What to do
2 units
Product description
There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.