FDA-Device2021-12-29Class II

VirtuTRAX Instrument Navigator, 14 Ga VirtuTRAX

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
9 boxes (5 units/box)
Manufactured in
102 1st St S, N/A, Kalona, IA, United States
Products
VirtuTRAX Instrument Navigator, 14 Ga VirtuTRAX

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0396-2022

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