FDA-Device2026-04-08Class IIPROCESSING DEFECT
Civco eTRAX Needle System Starter Kit recalled for incorrect needle position display
What this means
Civco Medical Instruments has recalled the eTRAX Needle System Starter Kit 14G due to a manufacturing error in the needle sensor for Aurora Trackers. The error may cause the needle tip position to display incorrectly on the device screen, which could affect proper placement during procedures.
- Stop using the eTRAX Needle System Starter Kit 14G (Part Number 667-150, Lot A228673) immediately
- Contact Civco Medical Instruments for instructions on returning or replacing the affected device
- Do not use this device until you receive guidance from the manufacturer
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
6 units
Manufactured in
102 1st St S, Kalona, IA, United States
Products
eTRAX Needle System Starter Kit 14G (for Aurora Trackers), Part Number 667-150
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1732-2026Want us to check the next one for you?
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