Recall Z-0452-2008 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
ConMed Electrosurgery
Conmed Accessory Electrode, Universal Electrodes, Part/REF Numbers : 138100 through 138-105, 138107, 138110, 138112 and 138113, and Ultra Clean Accessory Electrode, Part/REF Numbers: 139100, 139107, 139108, 139321, 139112, 139104 EXT. 139105EXT, 139110EXT, and 139112EXT, Sterile, Rx Only, Conmed Corporation, Utica, New York 13502.
| Date | Dec 11, 2007 (initiated Nov 2, 2007) |
| Status | Terminated |
| Reason | Sterility (package integrity) Compromised: packages of the electrosurgical blades and needles have an inadequate packaging seal |
| Root cause | Process design |
| Action | Consignees were notified by Urgent Voluntary Device Recall letter on 11/02/2007, from ConMed Corporation. They were asked to return affected product for replacement. |
| Quantity | 11,319 cases (476,160 units) |
| Distribution | Worldwide: USA and countries of Australia, Canada, China, Belgium, Chile, Denmark, Ecuador, France, Greece, India, Israel, Italy, Japan, Korea, Mexico, New Zealand, Norway, Philippines, Portugal, Saudi Arabia, South Africa, Spain, Thailand, Trinidad, and Uruguay. |
| FDA record | Open on fda.gov |