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Civco Medical Instruments Co. Inc.: eTRAX Needle System Starter Kit 16G(for Aurora Trackers), Part Number 667-151

Medical DevicesSource: FDA (device) · Date: 2026-04-08

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Civco Medical Instruments Co. Inc.
Product
eTRAX Needle System Starter Kit 16G(for Aurora Trackers), Part Number 667-151
Reason / 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.
Classification
Class II
Status
Ongoing
Distribution / sold at
US States: OH, PA, WA. China.
Recall initiated
2026-03-02
Code info
UDI-DI: 00841436111058; Lot Number: A228675, A228676, A233854, A268115, A268237, A272509, A277538, A280341
Product quantity
18 units
Voluntary mandated
Voluntary: Firm initiated
City
Kalona
State
IA
Country
United States
Event id
98513
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