Class 2 Device Recall VeinViewer

• Date Initiated by Firm: March 14, 2012
• Date Posted: March 22, 2012
• Recall Status: Terminated on October 23, 2012
• Recall Number: Z-1281-2012
• Recall Event ID: 61420
• Product Classification: Device, vein location, liquid crystal - Product Code KZA
• Product: VeinViewer (R) by Luminetx, Model Number VV1.1 GS, Part No. P00800-L, Luminetx Corporation, Memphis, TN 38104 Product Usage: CTS 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 02/11/2008  03/31/2011
• 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: 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: 600 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.