Recall Z-1099-2013 ยท OCX Endoscopic Irrigation/Suction System
US Endoscopy Group Inc
Torrent" irrigation tubing. Product Usage: The Torrent irrigation system (tubing and accessories to accommodate various endoscopes and irrigation pumps) is intended to provide irrigation via irrigation fluids, such as sterile water, during gastrointestinal endoscopic procedures when used in conjunction with an irrigation pump or electrosurgical unit.
| Date | Apr 11, 2013 (initiated Mar 7, 2013) |
| Status | Terminated |
| Reason | The firm was notified by their customers that there was a water leakage from the white tubing connector. |
| Root cause | Device Design |
| Action | US Endoscopy Group sent an Urgent Recall Notification letters to their customers. The letter identified the affected product, problem and actions to be taken. They instructed their customers to remove any of the affected products from their inventory and quarantine them. They also requested each customer complete the attached Customer Response Card and return it to US Endoscopy via fax at 1-440-639-4495 or by email at recall@endoscopy.com as soon as possible. For questions contact Customer Service at 1-800-769-8229. |
| Quantity | 21,189 units |
| Distribution | USA Nationwide Distribution - including the states of: AK, AL, AZ, CA, CO, CT, DE, FL, GA, ID, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI & WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K103239 | IRRIGATION SYSTEM United States Endoscopy Group, Inc., Dec 30, 2010 |