Home / Recalls / Civco Medical Instruments Co. Inc. / Z-0395-2022

Z-0395-2022 Class II Terminated

Recalled by Civco Medical Instruments Co. Inc. — Kalona, IA

Recall Details

Product Type
Devices
Report Date
December 29, 2021
Initiation Date
October 8, 2021
Termination Date
September 30, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
52 boxes (5 units/box)

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.

Distribution Pattern

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.

Code Information

Part Number 5350925; UDI 00841436100892; Lot Numbers: A117795, A119539, A121993, A129844, A131074, A131075, A131690, A142178

Other recalls by Civco Medical Instruments Co. Inc.

  • Z-1892-2025 Class II — BX2 Needle Guide, Part Number 644-094, tool for performing needle-guided (or cat (May 1, 2025)
  • Z-0398-2022 Class II — VirtuTRAX Instrument Navigator, 10 17 GA VirtuTRAX (October 8, 2021)
  • Z-0396-2022 Class II — VirtuTRAX Instrument Navigator, 14 Ga VirtuTRAX (October 8, 2021)
  • Z-0397-2022 Class II — VirtuTRAX Instrument Navigator, Sensor with 10 17 GA VirtutTRAX (October 8, 2021)
  • Z-0574-2019 Class II — CIVCO Needle Guide Bracket, REF 674-057, Reusable non-sterile bracket for use wi (November 2, 2018)
  • Z-0565-2019 Class II — CIVCO Biopsy Bracket, REF P03122-07, Reusable non-sterile single-angle bracket f (November 2, 2018)
  • Z-0572-2019 Class II — CIVCO Needle Guide Starter Kit, REF 674-038, Reusable non-sterile bracket with s (November 2, 2018)
  • Z-0564-2019 Class II — CIVCO Needle Guide Bracket, REF P03122-06, Reusable non-sterile bracket for use (November 2, 2018)
  • Z-0569-2019 Class II — CIVCO Needle Guide Starter Kit, REF numbers P12922-01 and P12922-02, Reusable no (November 2, 2018)
  • Z-0563-2019 Class II — SonoSite L25 Bracket Kit containing 1 Reusable non-sterile bracket, REF numbers (November 2, 2018)