FDA DevicesClass II
eTRAX Needle System Starter Kit 14G (for Aurora Trackers), Part Number 667-150
Published: April 8, 2026Recall ID: Z-1732-2026Category: devicesCountry: US
Reason for Recall / 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.
Product Description & Identification
eTRAX Needle System Starter Kit 14G (for Aurora Trackers), Part Number 667-150
Additional Source Details
| Field | Value |
|---|---|
| City | Kalona |
| State | IA |
| Event id | 98513 |
| Address 1 | 102 1st St S |
| Code info | UDI-DI: 00841436111041; Lot Number: A228673 |
| Postal code | 52247-9589 |
| Report date | 20260408 |
| Product type | Devices |
| Product quantity | 6 units |
| Reason for recall | 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260302 |
| Center classification date | 20260401 |
Overview
- Recalling FirmCivco Medical Instruments Co. Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionUS States: OH, PA, WA. China.