Recall Z-2239-2010 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Starion Instruments
The Starion Instruments Thermal Ligating Shears 35C Model 102-138D and 23C Model numbers 102-137D allow the surgeon to position the distal jaws of the instrument around the region of tissue to be cut/cauterized. The surgeon squeezes the handle and depresses the switch, heating elements activates in the jaws. The heat is conducted to the tissue between the jaws to provide cutting/cauterization. For
| Date | Aug 19, 2010 (initiated Mar 9, 2010) |
| Status | Terminated |
| Reason | The Starion Instruments Thermal Ligating Shears (STLS) 35C and the Starion Thermal Ligating Shears (STLS) 23C may turn on and remain on without the finger button being depressed. The devices may also work intermittently, incorrectly indicating the device is 'on". |
| Root cause | Device Design |
| Action | Starion distributed a "STLS Device Recall - Important Medical Device Information" letter dated March 9, 2010 to consignees. The letter identified the affected model and lot numbers. Consignees were asked to complete a inventory status form and fax to Starion. the letter included a shipping labe with a pre-assigned return authorization number. Starion will ship replacement after receipt of the inventory status form and returned product.. |
| Quantity | 228 units |
| Distribution | Worldwide Distribution: USA states of CA, OH, MI, KS and MO and countries of Italy, China, Kuwait, and Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062257 | STARION INSTRUMENTS THERMAL LITIGATING SHEARS Starion Instruments, Oct 10, 2006 |