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U.S. Department of Health and Human Services

Class 2 Device Recall VeinViewer

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  Class 2 Device Recall VeinViewer see related information
Date Initiated by Firm March 14, 2012
Date Posted March 22, 2012
Recall Status1 Terminated 3 on October 23, 2012
Recall Number Z-1280-2012
Recall Event ID 61420
Product Classification Device, vein location, liquid crystal - Product Code KZA
Product VeinViewer (R) by Luminetx, Model Number VV1.0, Part No: P00399-L, Luminetx Corporation, Memphis, TN 38104


Product Usage:
Non- invasive electronic visual aid device designed to project an image of a superficial subcutaneous vascular structures on the surface of the skin
Code Information All codes distributed between 05/02/2006  08/31/2011
Recalling Firm/
Manufacturer		 Christie Medical Holding Inc
1256 Union Ave
Memphis TN 38104
For Additional Information Contact Dawn Norman
901-721-0305
Manufacturer Reason
for Recall		 Instrument may tip over if not moved correctly.
FDA Determined
Cause 2		 Employee error
Action Christie Medical Holdings, Inc. sent an Urgent Medical Device Correction by letter on March 14, 2012 to all affected customers. The letter identified the product, problem and actions to be taken. The letter includes "Correct Transport" and "Do Not Pull labels to be applied to the unit. Customers were instructed to immediately examine their inventory, quarantine all product subject to correction and apply the labels prior to use. A Service Bulletin is enclosed that should be kept and placed with the User Guide for future reference and a Response Form to be completed and return as soon as possible. For questions contact Technical Service at 901-721-0300.
Quantity in Commerce 450 units
Distribution Worldwide Distribution - USA (nationwide) and the countries of: Argentina, Australia, China, Brazil, Czech Republic, Canada, Germany, Denmark, Spain, Great Britain, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, South Korea, Kuwait, Mexico, Malaysia, Netherlands, Norway, Philippines, Russian Federation, Saudi Arabia, Singapore, Thailand, Turkey, Taiwan, and United Arab Emirates
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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