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US Endoscopy Group Inc recalls Infinity¿ sampling device, Cytology Brush, United States Endoscopy Group, Inc., 5976 Heisley Road, Mentor, OH 44060 T
Recalled September 26, 2012 · FDA recall Z-2396-2012 · US Endoscopy Group
Hazard
US Endoscopy received five complaints which noted difficulty in deploying the cytology brush through the catheter. · FDA Class II
Units
393 Devices
Sold at
Worldwide Distribution - USA including CA, FL, GA, IA, IL, MA, ME, MN, MO, NC, NH, OH, OK, PA, TN, TX, VA, WA & WV and the countries of Australia, Canada, Columbia, Finland, Germany, India, Israel, Italy, Netherlands, New Zealand & United Kingdom.
Description
US Endoscopy received five complaints which noted difficulty in deploying the cytology brush through the catheter.
Product
Infinity¿ sampling device, Cytology Brush, United States Endoscopy Group, Inc., 5976 Heisley Road, Mentor, OH 44060 The Infinity sampling device is a disposable cytology brush used to retrieve cytological cell samples in the gastrointestinal tract.
Manufacturer(s)
US Endoscopy Group Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →