Recall Z-2598-2016 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Conmed Corporation
Adult Dual Dispersive Electrodes (for patients >15 kg.), use with the Birtcher Pad Sensing System (PSS) on the Birtcher Systems 6000, 6400, 6500 and CONMED Systems 7500 and 7550 ABC generators or conventional electrosurgery units with similar contact monitoring systems, 10' (3.05m) Cable, Catalog Number 7-382. Intended to be used for the dispersion and return to the electrosurgical generator.
| Date | May 18, 2016 |
| Status | Terminated |
| Reason | A version of the dual dispersive electrodes may not be compatible with some electrosurgical generators, placing patients at risk for undetected pad lift and a potential burn. |
| Root cause | Device Design |
| Action | On May 17, 2016 CONMED Corporation distributed Urgent Device Recall notification letters and Business Reply Forms to their customers via courier service. CONMED Corporation has decided to recall these ThermoGard Dual Dispersive Electrodes for all customers who do not use an electrosurgical generator that employs the Contact Quality Monitoring systems listed. If your electrosurgical generator is not listed, your generator should not be used with the lot codes of the ThermoGard Dual Dispersive Electrodes identified. Customers are advised to inspect inventory for any of the recalled devices. |
| Quantity | 124,333 units |
| Distribution | Worldwide Distribution -- USA, including AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, & Puerto Rico; and, the countries of Australia, Canada, Belgium, Brunei Darussalam, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K140658 | THERMOGARD DISPERSIVE ELECTRODES, THERMOGARD PLUS ABC DISPERSIVE ELECTRODES Conmed Corporation, Jul 10, 2014 |