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Recall Observatory FDA recall evidence

Device product

eTRAX Needle Sensor - 14G(for Aurora Trackers), Part Number 667-157

Z-1736-2026

March 02, 2026

Class II

Product summary

Firm
Civco Medical Instruments Co. Inc.
Event
Event 98513
Status
Ongoing
Classification
Class II
Quantity
5 units
Official record key
device-enforcement:Z-1736-2026

Official wording

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 information: UDI-DI: 00841436111089; Lot Number: A276633

Distribution pattern: US States: OH, PA, WA. China.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.