Z-0395-2022 Class II Terminated
FDA device recall Z-0395-2022 was initiated by Civco Medical Instruments Co. Inc. on October 8, 2021 and is designated Class II. Reason for recall: There is potential that the VirtuTRAX device will not tighten onto the instrument to be used. The recall status is terminated (terminated September 30, 2024). Affected quantity: 52 boxes (5 units/box).
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