FDA-Device2026-04-08Class IIPROCESSING DEFECT
Civco eTRAX Needle System Starter Kit recalled for incorrect needle tip position display
What this means
Civco Medical Instruments identified a programming error in certain eTRAX needle sensors used with Aurora trackers. This error can cause the needle tip position to display incorrectly on the user interface, which may affect the accuracy of needle placement guidance.
- Check if your eTRAX Needle System Starter Kit (Part Number 667-151) matches one of the affected lot numbers: A228675, A228676, A233854, A268115, A268237, A272509, A277538, or A280341
- Stop using the device if your lot number is listed
- Contact Civco Medical Instruments for instructions on replacement or correction
The agency's original wording
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.
Intended for
Adults
Illnesses reported
None reported
Sold states
US States: OH, PA, WA. China.
Affected count
18 units
Manufactured in
102 1st St S, Kalona, IA, United States
Products
eTRAX Needle System Starter Kit 16G(for Aurora Trackers), Part Number 667-151
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1733-2026Want us to check the next one for you?
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