Infinity¿ sampling device, Cytology Brush, United States Endoscopy Group, Inc., 5976 Heisley Road...
FDA Recall #Z-2396-2012 — Class II — December 22, 2011
Product Description
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.
Reason for Recall
US Endoscopy received five complaints which noted difficulty in deploying the cytology brush through the catheter.
Recalling Firm
US Endoscopy Group Inc — Mentor, OH
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
393 Devices
Distribution
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.
Code Information
Lot numbers 49680, 50793, 50794, 50795, 52577 & 53023.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated