VeinViewer (R) by Luminetx, Model Number VV1.0, Part No: P00399-L, Luminetx Corporation, Memphis, TN 38104 Product Usage

FDA device recall Z-1280-2012 · posted 2012-03-22 · Terminated

Recall details

Recalling firm

Christie Medical Holding Inc

Reason for recall

Instrument may tip over if not moved correctly.

Action taken

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

Status

Terminated

Product code

KZA

Quantity affected

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,

Date initiated

2012-03-14

Date posted

2012-03-22

Date terminated

2012-10-23

Location

Memphis, TN