FDA-Device2026-04-08Class IIPROCESSING DEFECT
Civco eTRAX Needle System Starter Kit recalled for inaccurate needle position display
What this means
Civco Medical Instruments Co. Inc. is recalling certain eTRAX Needle System Starter Kits (18G) used with Aurora Trackers due to a manufacturing error. The needle sensor may not correctly show the needle tip position on the display, which could affect proper use of the device.
- Check if you have lot number A233347, A228677, A268116, A268238, A272513, A279457, A280388, or A281840
- Stop using the affected eTRAX Needle System Starter Kit immediately
- Contact Civco Medical Instruments for instructions on how to return or replace your device
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
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-1734-2026Want us to check the next one for you?
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