Recall Z-1998-2009 · FDG Retractor, Fiberoptic

Lumitex Inc

Ultra-Thin LightMat Surgical Illuminator, Disposable one time use. Model Number: UA2550, Exp Date: 2012-05. Product is packaged in individual sterile pouch w/5 pouches per box. The LightMat is intended for the illumination of surgical procedures, particularly where deep cavities or adjacent tissues limit outside light in the surgical field.

Date	Sep 3, 2009 (initiated Jul 1, 2009)
Status	Terminated
Reason	Adhesive which is used to attach LightMat to retractor may not have been tested to Medical standards. The vendor provided an adhesive strip that did not conform to Lumitex specifications. The adhesive strip provided may not have met Lumitex requirements to be medical grade, EtO compatible, and biocompatible.
Root cause	Nonconforming Material/Component
Action	Lumitex, Inc. issued a recall letter dated July 2, 2009 to their Customers describing the affected device and requesting its return. For further information, contact Lumitex, Inc. at 1-440-243-8401.
Quantity	59 packs/5 individual units
Distribution	Product was distributed to the following states: CA, FL, KS, MA, ME, MI , NC, NM, NV, NY, OH, and TX.
FDA record	Open on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.