Recall Z-1943-2015 ยท OCX Endoscopic Irrigation/Suction System
US Endoscopy Group Inc
Velocity" Biopsy Valve, 25 units per box, Product Usage: The disposable Velocity biopsy valve is used to cover the opening of the biopsy inlet port of a flexible gastrointestinal endoscope. The Velocity biopsy valve provides access for endoscopic device passage and exchange, helps maintain insufflation, and minimizes leakage of biomaterial from the accessory port throughout the gastrointestinal
| Date | Jul 1, 2015 (initiated Feb 17, 2015) |
| Status | Terminated |
| Reason | The company has received reports of structural non conformance at the connection between the valve body and the irrigation tube, resulting in separation of the components during use. |
| Root cause | Under Investigation by firm |
| Action | US Endoscopy sent an Urgent Recall Notification Letter dated to their customers. The letter identified the affected product, problem and actions to be taken. US Endoscopy requests that their customers: 1. Remove all unused affected Velocity Biopsy Valves from your inventory. 2. Complete the attached Customer Response Card and return to the attention of Kia Pennington, via fax 1-440-639-4495 or email kpenning@usendoscopy.com. 3. Mark the shipping container with code: RMA xxxxxxxx QIF, and return the product to US Endoscopy via Fed Ex Account #293799547. For questions contact Kia Pennington i |
| Quantity | 2,173 units |
| Distribution | Worldwide Distribution - US Nationwide in the states of: CA, CO, IA, MA, OH, TX & WV and the countries of: Brazil, Costa Rica, Croatia, Czech Republic, Egypt, France, Germany, India, Indonesia, Italy, Latvia, Lithuania, Philippines, Poland, Romania, Russian Federation, Slovenia & South Africa. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092461 | IRRIGATION PUMP, IRRIGATION BIOPSY VALVE, ,MODEL 00711520, 00711139, 00711140 United States Endoscopy Group, Inc., Nov 5, 2009 |