Device product
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.
Z-2396-2012
Product summary
- Event
- Event 63047
- Status
- Terminated
- Classification
- Class II
- Quantity
- 393 Devices
- Official record key
device-enforcement:Z-2396-2012
Official wording
Reason: US Endoscopy received five complaints which noted difficulty in deploying the cytology brush through the catheter.
Code information: Lot numbers 49680, 50793, 50794, 50795, 52577 & 53023.
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.
Derived failure modes
-
Unknown
US Endoscopy received five complaints which noted difficulty in deploying the cytology brush through the catheter.