Home / Recalls / US Endoscopy Group Inc / Z-2396-2012

Z-2396-2012 Class II Terminated

Recalled by US Endoscopy Group Inc — Mentor, OH

Recall Details

Product Type
Devices
Report Date
September 26, 2012
Initiation Date
December 22, 2011
Termination Date
March 22, 2013
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
393 Devices

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.

Distribution Pattern

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.

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