| Class 2 Device Recall VirtuTRAX | |
Date Initiated by Firm | October 08, 2021 |
Create Date | December 20, 2021 |
Recall Status1 |
Terminated 3 on September 30, 2024 |
Recall Number | Z-0395-2022 |
Recall Event ID |
88906 |
510(K)Number | K092619 |
Product Classification |
System, imaging, pulsed echo, ultrasonic - Product Code IYO
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Product | VirtuTRAX Instrument Navigator, Sensor with 14 Ga VirtutTRAX |
Code Information |
Part Number 5350925; UDI 00841436100892; Lot Numbers: A117795, A119539, A121993, A129844, A131074, A131075, A131690, A142178 |
Recalling Firm/ Manufacturer |
Civco Medical Instruments Co. Inc. 102 1st St S Kalona IA 52247-9589
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For Additional Information Contact | 319-248-6500 |
Manufacturer Reason for Recall | There is potential that the VirtuTRAX device will not tighten onto the instrument to be used. |
FDA Determined Cause 2 | 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 in Commerce | 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.
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Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = IYO
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