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
FDA Recall Z-1280-2012 · Posted 2012-03-22
Recalling FirmChristie Medical Holding Inc
Recall StatusTerminated
Product CodeKZA
Date Initiated2012-03-14
Date Terminated2012-10-23
Product Quantity450 units
Reason for Recall
Instrument may tip over if not moved correctly.
Firm 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.
Root Cause
Employee error
Distribution Pattern
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
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.