Recall Z-1301-04 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Conmed Corporation
ConMed Stealth coated Laparoscopic Electrodes with 4mm Pin (60-5158 series). Cat. #60-5158-034 - Spatula; Cat. #60-5158-234 -''J'' Hook; Cat. #60-5158-432 - ''L'' Hook; Cat. # 60-5158-934 - Needle. FIRM ON LABEL: ConMed Corporation, Utica, New York, USA 13502.
| Date | Jul 31, 2004 (initiated Jun 28, 2004) |
| Status | Terminated |
| Reason | Insulation of some electrodes may have pulled away from the hub of the electrode exposing the conductive shaft below. There is potential for electrical shock. |
| Root cause | Other |
| Action | Letters dated 6/28/04 via Priority Mail with instructions to return product and to subrecall if further distributed. |
| Quantity | 3,252 units |
| Distribution | Nationwide distribution to 24 hospitals, 3 distributors and 13 sales reps. Six foreign consignees in Mexico, Italy, United Kingdom, Spain, Turkey and Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K960808 | CONMED SELECT ONE LAPAROSCOPY ELECTRODE Conmedcorp, Mar 21, 1996 |