Recall Z-0395-2022— Civco Medical Instruments Co. Inc.

Name: FDA recall Z-0395-2022
Creator: U.S. Food and Drug Administration
Published: 2021-10-08

Class II · Terminated

Class II FDA medical device recall by Civco Medical Instruments Co. Inc., initiated 2021-10-08, terminated 2024-09-30. It names one FDA 510(k) clearance: K092619. Product: VirtuTRAX Instrument Navigator, Sensor with 14 Ga VirtutTRAX. Reason: There is potential that the VirtuTRAX device will not tighten onto the instrument to be used..

Recalling firm: Civco Medical Instruments Co. Inc.
Classification: Class II
Status: Terminated
Initiated: 2021-10-08
Terminated: 2024-09-30
Firm location: Kalona, IA, United States

510(k) clearances named in this recall

1 on FDA's record

K092619 — ETRAX NEEDLE SYSTEM, ETRAX VARIABLE ANGLE NEEDLE GUIDANCE SYSTEM, VIRTUTRAX UNIVERSAL TRACKERCivco·cleared 2009-11-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

VirtuTRAX Instrument Navigator, Sensor with 14 Ga VirtutTRAX

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.