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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 VirtuTRAXsee related information
Date Initiated by FirmOctober 08, 2021
Create DateDecember 20, 2021
Recall Status1 Terminated 3 on September 30, 2024
Recall NumberZ-0397-2022
Recall Event ID 88906
510(K)NumberK092619 
Product Classification System, imaging, pulsed echo, ultrasonic - Product Code IYO
ProductVirtuTRAX Instrument Navigator, Sensor with 10 17 GA VirtutTRAX
Code Information Part Number 610-1080; UDI 00841436101936; Lot Numbers: A109102, A109175, A121363, A129087, A129088, A131042, A133436, A134220, A138099, A139369, A140674, A141818
Recalling Firm/
Manufacturer		 Civco Medical Instruments Co. Inc.
102 1st St S
Kalona IA 52247-9589
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
ActionThe 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 Commerce18 boxes (5 units/box)
DistributionWorldwide 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 CycleTPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = IYO
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