Recall Z-1456-05 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Boston Scientific Corp
Boston Scientific brand Concerto Bipolar Needle Electrode, sterile, latex free, Model M001262400, catalog number 26-240.
| Date | Aug 31, 2005 (initiated Jul 15, 2005) |
| Status | Terminated |
| Reason | The distal tip may dislodge from the device during use and the firm has received complaints of electrical errors. |
| Root cause | Other |
| Action | Consignees were advised by recall letter dated July 25, 2005 and requested to return all units on hand. |
| Quantity | 115 |
| Distribution | Nationwide, Germany, Italy, Netherlands, Spain and Sweden. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.