Recall Z-0001-2016 ยท FDI Snare, Flexible
US Endoscopy Group Inc
Histolock Resection Device, US Endoscopy. An electrosurgical device designed to be used to endoscopically grasp, dissect and transect tissue during gastrointestinal endoscopic procedures.
| Date | Oct 1, 2015 (initiated Jul 14, 2015) |
| Status | Terminated |
| Reason | The company has determined the sterility cannot be assured for the affected lot. |
| Root cause | Employee error |
| Action | The firm, US Endoscopy, sent an "URGENT: HISTOLOCK" RESECTION DEVICE RECALL" letter and response form to their customers on July 14, 2015. The letter described the product, problem and action to be taken. The customers were instructed to complete the response form and return to your US Endoscopy Product Specialist and retain a copy of the letter for your records. If you have any questions, contact Sr. Manager, Reg. Affairs & Quality Compliance at 440-358-6251 or email at: ccochara@usendoscopy.com. |
| Quantity | 41 units |
| Distribution | US Distribution to states of: AL, AR, CA, IL, IN, MS, OH, OK & TN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K140763 | MONOFILAMENT POLYPECTOMY SNARE United States Endoscopy, Apr 24, 2014 |