Z-1281-2012

VeinViewer (R) by Luminetx, Model Number VV1.1 GS, Part No. P00800-L, Luminetx Corporation, Memphis, TN 38104

Name: Z-1281-2012 VeinViewer (R) by Luminetx, Model Number VV1.1 GS, Part No. P00800-L, Luminetx Corporation, Memphis, TN 38104
Creator: Christie Medical Holding Inc
Published: 2012-03-14
License: https://open.fda.gov/license/

Christie Medical Holdings, Inc. / initiated 2012-03-14 / Terminated / root cause: manufacturing process

FDA source

Christie Medical Holding Inc began a recall of VeinViewer (R) by Luminetx, Model Number VV1.1 GS, Part No. P00800-L, Luminetx Corporation, Memphis, TN 38104 Product Usage: CTS Usage: Non- invasive... on 2012-03-14. The reason FDA records is "Instrument may tip over if not moved correctly". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1281-2012
Status: Terminated
Initiated: 2012-03-14
Posted: 2012-03-22
Terminated: 2012-10-23
Recalling firm: Christie Medical Holdings, Inc.
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
Product code: KZA Device, Vein Location, Liquid Crystal
Reason for recall: Instrument may tip over if not moved correctly.
Root cause tag: manufacturing process
FDA root 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
Product codes and lots: All codes distributed between 02/11/2008 03/31/2011

Product code KZA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)