FDA-Device2021-12-29Class II

VirtuTRAX Instrument Navigator, Sensor with 14 Ga VirtutTRAX

Civco Medical Instruments Co. Inc.
Hazard

There is potential that the VirtuTRAX device will not tighten onto the instrument to be used.

Sold states
Worldwide distribution - US Nationwide and the countries of Belgium, Canada, China (Mainland), China (Taiwan), Denmark, France, Germany, Italy, Japan, Netherlands, Singapore, South Korea, Spain, Thailand.
Affected count
52 boxes (5 units/box)
Manufactured in
102 1st St S, N/A, Kalona, IA, United States
Products
VirtuTRAX Instrument Navigator, Sensor with 14 Ga VirtutTRAX

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0395-2022

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