FDA-Device2026-04-08Class II
eTRAX Needle System Starter Kit 18G (for Aurora Trackers), Part Number 667-152
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
20 units
Manufactured in
102 1st St S, Kalona, IA, United States
Products
eTRAX Needle System Starter Kit 18G (for Aurora Trackers), Part Number 667-152
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1734-2026Original summary
eTRAX Needle System Starter Kit 18G (for Aurora Trackers), Part Number 667-152 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: 00841436111065; Lot Number: A233347, A228677, A268116, A268238, A272513, A279457, A280388 , A281840 Distribution: US States: OH, PA, WA. China. Affected quantity: 20 units
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