Recall Z-2400-2011 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Encision, Inc.
ES0102-45, AEM Disposable Curved Scissors, 3/4", 45cm, Sterile R, Encision Inc., Boulder, CO 80301 Cutting tissue during electrosurgical procedures
| Date | May 31, 2011 (initiated Apr 7, 2011) |
| Status | Terminated |
| Reason | Sterility may be compromised due to holes in packaging. |
| Root cause | Package design/selection |
| Action | Encision, Inc. sent an Important Safety Notice letter dated April 7, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to either carefully inspect any remaining pouches for readily visible holes in the Tyvek pouch, or return the affected lots to Encision for inspection. Customers were also asked to fill in and fax back the attached Confirmation to 303-444-2693. |
| Quantity | 95 Ten-Count Boxes |
| Distribution | Worldwide Distribution - USA (nationwide) and the countries of Australia and New Zealand |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K912780 | MONOPOLAR LAPAROSCOPIC ELECTRODES W/ELETROSHIELD Electroscope, Inc., Dec 30, 1991 |