FDA DevicesClass II
eTRAX Needle System Starter Kit 16G(for Aurora Trackers), Part Number 667-151
Published: April 8, 2026Recall ID: Z-1733-2026Category: 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 16G(for Aurora Trackers), Part Number 667-151
Additional Source Details
| Field | Value |
|---|---|
| City | Kalona |
| State | IA |
| Event id | 98513 |
| Address 1 | 102 1st St S |
| Code info | UDI-DI: 00841436111058; Lot Number: A228675, A228676, A233854, A268115, A268237, A272509, A277538, A280341 |
| Postal code | 52247-9589 |
| Report date | 20260408 |
| Product type | Devices |
| Product quantity | 18 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.