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U.S. Department of Health and Human Services

Class 2 Device Recall UltraThin LightMat Surgical Illuminator

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 Class 2 Device Recall UltraThin LightMat Surgical Illuminatorsee related information
Date Initiated by FirmJuly 01, 2009
Date PostedSeptember 03, 2009
Recall Status1 Terminated 3 on March 09, 2012
Recall NumberZ-1998-2009
Recall Event ID 52817
Product Classification Retractor, fiberoptic - Product Code FDG
ProductUltra-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.
Code Information Model Number: UA2550; Lot Number: I01161.
FEI Number 1000122810
Recalling Firm/
Manufacturer		 Lumitex Inc
8443 Dow Cir
Strongsville OH 44136
For Additional Information ContactVivian McLaughlin
440-243-8401 Ext. 124
Manufacturer 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.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionLumitex, 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 in Commerce59 packs/5 individual units
DistributionProduct was distributed to the following states: CA, FL, KS, MA, ME, MI , NC, NM, NV, NY, OH, and TX.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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