FDA (Devices) recall action 98513
The FDA (Devices) publishes a recall like this one as 8 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 8 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Civco is recalling the eTRAX Needle Sensor 14G for Aurora trackers because an inspection and programming error may cause the needle tip position to be incorrectly identified.
Civco is recalling the eTRAX Needle System Starter Kit 16G for Aurora trackers because an inspection and programming error may cause the needle tip position to be incorrectly identified.
Civco is recalling the eTRAX Needle Sensor 18G for Aurora trackers because an inspection and programming error may cause the needle tip position to be incorrectly identified.
Civco is recalling the eTRAX Needle System Starter Kit 14G for Aurora trackers because an inspection and programming error may cause the needle tip position to be incorrectly identified.
Civco is recalling the eTRAX Needle System Starter Kit 18G for Aurora trackers because an inspection and programming error may cause the needle tip position to be incorrectly identified.
Civco is recalling the eTRAX Needle Sensor 16G for Aurora trackers because an inspection and programming error may cause the needle tip position to be incorrectly identified on the user interface.
Civco is recalling the eTRAX Needle System Starter Kit 12G for Aurora trackers because an inspection and programming error may cause the needle tip position to be incorrectly identified.
Civco is recalling the eTRAX Needle Sensor 12G for Aurora trackers because an inspection and programming error may cause the needle tip position to be incorrectly identified.