FDA DeviceClass IINotable

FDA Recall: eTRAX Needle System Starter Kit 12G (for Aurora Trackers), Part Number 667-149

Date: 2026-04-08
Brand: Civco Medical Instruments Co. Inc.
Category: Medical Device
FDA Class: Class II

Description

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.

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.

Remedy

2 units

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