Recall Z-2396-2012 ยท KOG
US Endoscopy Group Inc
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.
| Date | Sep 17, 2012 (initiated Dec 22, 2011) |
| Status | Terminated |
| Reason | US Endoscopy received five complaints which noted difficulty in deploying the cytology brush through the catheter. |
| Root cause | Nonconforming Material/Component |
| Action | US Endoscopy sent an Addendum and Correction to the Instructions for Use letter dated December 22, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to rinse the brush head with sterile water immediately prior to use (reference the attached Addendum. Customers were also instructed to retract and deploy the brush to ensure that is is functioning properly prior to use. Customers were asked to review the instruction for use for this product along with the Addendum to ensure proper usage and pe |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K103437 | US ENDOSCOPY CYTOLOGY BRUSH United States Endoscopy Group, Inc., Dec 23, 2010 |