U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Retractor, fiberoptic - Product Code FDG
원인
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.
조치
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.
Product was distributed to the following states: CA, FL, KS, MA, ME, MI , NC, NM, NV, NY, OH, and TX.
제품 설명
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.