Recall Z-0140-2010 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Kentucky Packaging Service LP
Olsen Medical, MIDAS TOUCH NEEDLE ELECTRODE, WITH MODIFIED TIP. Model Numbers: 30-1011, 30-1012, 30-1013, 30-1014 and 30-6011.
| Date | Nov 10, 2009 (initiated Sep 24, 2009) |
| Status | Terminated |
| Reason | THERE WERE INCONSISTENCIES NOTICED ON THE INSULATION OVERLAP. THE ELECTRODE HAS A LARGE DIAMETER SHAFT THAT TRANSITIONS TO A SMALLER DIAMETER SHAFT. THE 1ST LAYER OF INSULATION WHICH COVERS THE SMALL DIAMETER SHAFT OVERLAPS WITH THE 2ND LAYER OF INSULATION THAT COVERS THE LARGER DIAMETER SHAFT. ON SOME ELECTRODES IT APPEARS THAT THE OVERLAP IS TOO SHORT TO COVER THE TRANSITION WHICH MAKES THIS |
| Root cause | Process control |
| Action | Olsen Medical issued an "Urgent: Device Recall" letter to Consignees beginning September 24, 2009 . Customers were instructed to inventory their stock and for all remaining product immediately discontinue use and return. Consignees were also instructed to contact their customers and notify them of the recall. For further information, contact Olsen Medical at 1-502-772-4272. |
| Quantity | 3,617 pieces |
| Distribution | Nationwide Distribution -- AZ, FL, IA, MD, MO, NM, OR, NV, TN, TX and VA. |
| 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 |