Device recall enforcement reports

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

Civco Medical Instruments Co. Inc. · 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 in…

Class IIOngoingZ-1736-2026
Status
Ongoing
City
Kalona
State
IA
Country
United States
Classification
Class II
Product type
Devices
Event ID
98513
Recalling firm
Civco Medical Instruments Co. Inc.
Address 1
102 1st St S
Postal code
52247-9589
Voluntary mandated
Voluntary: Firm initiated
Distribution pattern
US States: OH, PA, WA. China.
Recall number
Z-1736-2026
Product description
eTRAX Needle Sensor - 14G(for Aurora Trackers), Part Number 667-157
Product quantity
5 units
Recall initiation date
20260302
Center classification date
20260401
Report date
20260408
Code info
UDI-DI: 00841436111089; Lot Number: A276633
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.

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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.