United StateseTRAX Needle System Starter Kits (12G, 14G, 16G, 18G) and eTRAX Needle Sensors (12G, 14G, 16G, 18G) for Aurora Trackers, part numbers 667-149, 667-150, 667-151, 667-152, 667-156, 667-157, 667-158 and 667-159, plus listed UDI-DI and lot numbers, sold in Ohio, Pennsylvania, Washington and China are affected. An error in inspection and programming of the eTRAX needle sensor can result in the needle tip position being incorrectly identified on the user interface.
What's being recalled
eTRAX Needle System Starter Kit 12G (for Aurora Trackers), Part Number 667-149
eTRAX Needle System Starter Kit 14G (for Aurora Trackers), Part Number 667-150
eTRAX Needle System Starter Kit 16G(for Aurora Trackers), Part Number 667-151
eTRAX Needle System Starter Kit 18G (for Aurora Trackers), Part Number 667-152
eTRAX Needle Sensor - 12G (for Aurora Trackers), Part Number 667-156
eTRAX Needle Sensor - 14G(for Aurora Trackers), Part Number 667-157
eTRAX Needle Sensor - 16G(for Aurora Trackers), Part Number 667-158
eTRAX Needle Sensor - 18G (for Aurora Trackers), Part Number 667-159
Recalling firm: Civco Medical Instruments Co. Inc., Kalona, IA, United States.
How to identify it
UDI-DI: 00841436111034; Lot Number: A228672 UDI-DI: 00841436111041; Lot Number: A228673 UDI-DI: 00841436111058; Lot Number: A228675, A228676, A233854, A268115, A268237, A272509, A277538, A280341 UDI-DI: 00841436111065; Lot Number: A233347, A228677, A268116, A268238, A272513, A279457, A280388 , A281840 UDI-DI: 00841436111072; Lot Number: A276634 UDI-DI: 00841436111089; Lot Number: A276633 UDI-DI: 00841436111096; Lot Number: A276636, A282454 UDI-DI: 00841436111102; Lot Number: A257459, A252198, A268105, A276632
The 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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US States: OH, PA, WA. China.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)