FDA-Device2012-09-26Class II
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.
US Endoscopy Group Inc
Hazard
US Endoscopy received five complaints which noted difficulty in deploying the cytology brush through the catheter.
Sold states
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.
Affected count
393 Devices
Manufactured in
5976 Heisley Rd, Mentor, OH, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2396-2012Don't want to check this manually?
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