Recall Z-1323-2015 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
ArthroCare Medical Corporation
Coblator II System, 120V. Product Usage: The Coblator II (Model RF8000E) is a bipolar, radiofrequency electrosurgical system designed for use in otorhinolaryngology (ENT) surgery. The system consists of the following components: an electrosurgical radiofrequency controller, a reusable, non-sterile Power Cord; a reusable, non-sterile Foot Control; a reusable, non-sterile Flow control Valve Unit;
| Date | Mar 26, 2015 (initiated Feb 20, 2015) |
| Status | Terminated |
| Reason | The recalling firm was notified by the contract manufacturer that they had reversed the L2, L3, L4, or L5 components on the P/N09010 RoHS boards of the Coblator II Controller (Model RF8000E). |
| Root cause | Packaging process control |
| Action | ArthroCare sent an Urgent Medical Device Recall letter dated February 2015 to customers. A response form will be included in the letter and a follow up notifcation letter will be sent to non-responding consignees. The letter identified the affected product, problem and actions to be taken. For questions contact your local Returns Department Representative at 800-343-5717, option 3. |
| Quantity | 15 units |
| Distribution | US Nationwide Distribution in the states of TN, IA, AZ, NE, SD, NY, and OK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030108 | ARTHROCARE ENT COBLATOR SURGERY SYSTEM Arthrocare Corp., Feb 3, 2003 |