FDA-Device2026-04-08Class II
eTRAX Needle System Starter Kit 12G (for Aurora Trackers), Part Number 667-149
Civco Medical Instruments Co. Inc.
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.
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-1731-2026Original summary
eTRAX Needle System Starter Kit 12G (for Aurora Trackers), Part Number 667-149 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. UDI-DI: 00841436111034; Lot Number: A228672 Distribution: US States: OH, PA, WA. China. Affected quantity: 2 units
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