Recall Z-1539-2010 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Encision, Inc.
AEM Disposable Electrode, Spatula, 35cm, REF ES0301, Qty: 10 each Sterile R, Manufactured for: Encision Inc., Boulder, CO 80301, made in Taiwan. Electrosurgical accessories intended, by use of monopolar high-frequency electrical current from compatible electrosurgical generators, for ablation, removal, resection and coagulation of soft tissue where associated hemostasis is required in open, endos
| Date | May 6, 2010 (initiated Apr 5, 2010) |
| Status | Terminated |
| Reason | Electrosurgical electrode tip insulation may crack and break off during use. |
| Root cause | Nonconforming Material/Component |
| Action | A "Confirmation of Product Recall" letter dated April 5, 2010, was faxed by the firm (Encision, Inc.) to all customers. The letter describes the product, problem and action to be taken by customers. The customers were instructed to either return or destroy the affected electrodes and to contact any customers or sales representatives to whom they distributed the product and confirm they have been removed from use and/or they will pick them up for return. The customers is to complete form and fax to the attention of RA/QA at 1-303-444-2693 or return with the items. The number to call to arran |
| Quantity | 260 units |
| Distribution | Worldwide distribution: USA including states of CA, CT, IA, IN, KS, KY, MI, OK, TX, WV, and countries of New Zealand and The Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K091074 | AEM DISPOSABLE ELECTRODES,MODEL ESO300 SERIES Encision, Inc., Aug 17, 2009 |