Recall Z-0627-2010 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Sorin Group USA, Inc.
Sorin / Clearglide EVH Low Profile with Scissor, REF KTV18, Sterile R, Manufactured for: Sorin Group USA, Inc., 14401 W.65th Way, Arvada, CO 80004. The device is indicated for endoscopic and open tissue dissection, bipolar coagulation, and transaction of blood vessels. Device is a single patient use bipolar instrument that uses a bipolar electrosurgical generator and is used predominately for end
| Date | Jan 14, 2010 (initiated Nov 25, 2009) |
| Status | Terminated |
| Reason | Vessel clamping device may break during use. |
| Root cause | Component change control |
| Action | Consignees were notified by "Urgent Field Safety Notice" dated November 24, 2009 with instructions to examine the device before, during and after use. Customers were instructed to not use the device, if it is damaged. Customers were also instructed to contact the Sorin Group Customer Service at 1-800-650-2623 to arrange shipment of replacement product and requested to complete and return the response form. Direct questions to the Sorin Group Customer Service at 1-800-650-2623. |
| Quantity | 444 units |
| Distribution | Worldwide Distribution -- United States, Australia, Canada and Italy. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K003587 | CLEARGLIDE PRECISION BIPOLAR DEVICE ETHICON, Inc., Dec 4, 2000 |