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.
This recall has been terminated (originally issued September 3, 2009).
- Company
- Lumitex Inc
- Recall Initiated
- July 1, 2009
- Posted
- September 3, 2009
- Terminated
- March 9, 2012
- Recall Number
- Z-1998-2009
- Quantity
- 59 packs/5 individual units
- Firm Location
- Strongsville, OH
- Official Source
- View on FDA website ↗
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.
Distribution
Product was distributed to the following states: CA, FL, KS, MA, ME, MI , NC, NM, NV, NY, OH, and TX.
Lot / Code Info
Model Number: UA2550; Lot Number: I01161.
Root Cause
Nonconforming Material/Component
Action Taken
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.