Z-2396-2012 Class II Terminated
FDA device recall Z-2396-2012 was initiated by US Endoscopy Group Inc on December 22, 2011 and is designated Class II. Reason for recall: US Endoscopy received five complaints which noted difficulty in deploying the cytology brush through the catheter. The recall status is terminated (terminated March 22, 2013). Affected quantity: 393 Devices.
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.