FDA recall Z-0396-2022

Product

VirtuTRAX Instrument Navigator, 14 Ga VirtuTRAX

Reason for recall

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

Distribution

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.

Key facts

Status

Terminated

Initiation date

2021-10-08

Report date

2021-12-29

Termination date

2024-09-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Kalona, IA, United States

Primary source

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