FDA Enforcement
Class II
Ongoing
eTRAX Needle Sensor - 12G (for Aurora Trackers), Part Number 667-156
Recall: Z-1735-2026
·
Reported April 8, 2026
Enforcement
- Recall Number
- Z-1735-2026
- Event ID
- 98513
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Civco Medical Instruments Co. Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Report Date
- April 8, 2026
- Initiation Date
- March 2, 2026
- Classification Date
- April 1, 2026
- Address
- 102 1st St S, Kalona, IA, 52247-9589, United States
Description
eTRAX Needle Sensor - 12G (for Aurora Trackers), Part Number 667-156
Reason
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.
Code Info
UDI-DI: 00841436111072; Lot Number: A276634
Distribution
US States: OH, PA, WA. China.
Quantity
5 units