FDA Medical Device Recalls (openFDA)
Civco Medical Instruments Co. Inc.: VirtuTRAX Instrument Navigator, Sensor with 14 Ga VirtutTRAX
- Recall number
- Z-0395-2022
- Recalling firm
- Civco Medical Instruments Co. Inc.
- Product
- VirtuTRAX Instrument Navigator, Sensor with 14 Ga VirtutTRAX
- Status
- Terminated
- Initiated
- 2021-10-08
- Posted
- not on file
- Terminated
- 2024-09-30
- Reason
- There is potential that the VirtuTRAX device will not tighten onto the instrument to be used.
- Root cause
- Device Design
- Action
- The firm distributed an "URGENT: MEDICAL DEVICE RECALL" notice on 10/21/2021 by email. The notice explained the problem and requested acknowledgement of the notice. Entities further distributing the products were directed to notify those to whom the devices were distributed. The firm will be replacing the units.
- Quantity
- 52 boxes (5 units/box)
- 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.
- Lot, serial or model codes
- Part Number 5350925; UDI 00841436100892; Lot Numbers: A117795, A119539, A121993, A129844, A131074, A131075, A131690, A142178
- 510(k) numbers
- ["K092619"]
- PMA numbers
- not on file
- Product code
- IYO
- Firm FEI
- 1937223
- Firm city
- Kalona
- Firm state
- IA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28