FDA-Device2026-04-08Class IIPROCESSING DEFECT

Civco eTRAX Needle System Starter Kit recalled for incorrect needle position display

What this means

Civco Medical Instruments identified a programming error in the eTRAX Needle System Starter Kit 12G (Part Number 667-149) for Aurora Trackers. This error can cause the needle tip position to display incorrectly on the user interface, potentially affecting procedure accuracy. Two units were affected and distributed to Ohio, Pennsylvania, and Washington.

Stop using the eTRAX Needle System Starter Kit 12G (Part Number 667-149) immediately
Check if you have lot number A228672
Contact Civco Medical Instruments for instructions on replacement or return

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

2 units

Manufactured in

102 1st St S, Kalona, IA, United States

Products

eTRAX Needle System Starter Kit 12G (for Aurora Trackers), Part Number 667-149

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1731-2026

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