Recall Z-0182-2007 ยท JOS Electrode, Electrosurgical
Olsen Medical
MIDAS TOUCH Electrosurgical/102 mm (4 inch) Blade Electrodes, Disposable, Sterile Single Use Device, Part #30-0012 and #30-0002. The electrodes are individually packaged in Tyvek bags with 12 packages per case.
| Date | Nov 15, 2006 (initiated Aug 29, 2006) |
| Status | Terminated |
| Reason | Testing conducted by the firm indicates that electrodes identified with certain part numbers may fall out from the electrosurgical pencil or handle presenting the potential for harm or injury to the patient and/or user. |
| Root cause | Other |
| Action | The firm issued an ''Urgent: Device Recall'' notification to their customers via letter and E-mail on 8/29/2006 and 8/30/2006. The letter informs the customers of this problem and asks that the customers contact their sub-accounts and notify them of the problem if they have further distributed any of the suspect part numbers. The letter also asks that the distributor/customer(s) have the subaccounts discontinue use of the product; and return the held product to the distributor (who in turn, should return the product to Olsen Medical for reimbursement). The customers are asked to complete and |
| Quantity | 81 cases/972 pieces |
| Distribution | Worldwide, including USA, Japan, and New Zealand. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K973234 | MIDAS TOUCH ELECTROSURGICAL ELECTRODE Iti Medical Technologies, Inc., Oct 27, 1997 |