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U.S. Department of Health and Human Services

Class 2 Device Recall VirtuTRAX

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  Class 2 Device Recall VirtuTRAX see related information
Date Initiated by Firm October 08, 2021
Create Date December 20, 2021
Recall Status1 Open3, Classified
Recall Number Z-0396-2022
Recall Event ID 88906
510(K)Number K092619  
Product Classification System, imaging, pulsed echo, ultrasonic - Product Code IYO
Product VirtuTRAX Instrument Navigator, 14 Ga VirtuTRAX
Code Information Part Number 610-1153; UDI 00841436102285; Lot Numbers: A122182, A131167, A131689, A131691, A141823
Recalling Firm/
Civco Medical Instruments Co. Inc.
102 1st St S
Kalona IA 52247-9589
For Additional Information Contact
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 9 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.
Total Product Life Cycle TPLC Device Report

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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = IYO and Original Applicant = CIVCO