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.
FDA Recall Z-1998-2009 · Posted 2009-09-03
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Recalling FirmLumitex Inc
Recall StatusTerminated
Product CodeFDG
Date Initiated2009-07-01
Date Terminated2012-03-09
Product Quantity59 packs/5 individual units
Reason for Recall
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.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Product was distributed to the following states: CA, FL, KS, MA, ME, MI , NC, NM, NV, NY, OH, and TX.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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