Recall Z-0031-06 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Rita Medical Systems
Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
| Date | Oct 7, 2005 (initiated Sep 21, 2005) |
| Status | Terminated |
| Reason | Devices for which sterility may be compromised as evidenced by a loss of package integrity. |
| Root cause | Other |
| Action | On 9/21/05, the firm issued letters via UPS to all its direct consignees, informing them of the affected product and providing instructions on the recall. |
| Distribution | Product was released for distribution to 63 consignees nationwide. The recall was appropriately extended to the consumer/user level; i.e., the physicians and hospitals who received the recalled product. There were no shipments to U.S. Government facilities or foreign or Canadian distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051420 | HABIB 4X Emcision , Ltd., Aug 15, 2005 |