FDA Enforcement
Class II
Terminated
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.
Recall: Z-2396-2012
·
Reported September 26, 2012
Enforcement
- Recall Number
- Z-2396-2012
- Event ID
- 63047
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- US Endoscopy Group Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Report Date
- September 26, 2012
- Initiation Date
- December 22, 2011
- Classification Date
- September 17, 2012
- Termination Date
- March 22, 2013
- Address
- 5976 Heisley Rd, Mentor, OH, 44060-1873, United States
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
US Endoscopy received five complaints which noted difficulty in deploying the cytology brush through the catheter.
Code Info
Lot numbers 49680, 50793, 50794, 50795, 52577 & 53023.
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.
Quantity
393 Devices