Recall Z-0799-05 ยท EGJ Device, Iontophoresis, Other Uses
Selectivemed Components Inc
Iontophoresis active electrode, small, 1.5cc capacity, sold as Model # NC89250B. Product is packaged in 12 treatment kit box labeled as Buffered Iontophoretic Delivery Electrode System Treatment Kit, 12 treatments.
| Date | May 6, 2005 (initiated Mar 15, 2005) |
| Status | Terminated |
| Reason | The conductor portion of the electrode is installed backwards, with the plastic and silver portions of the electrode reversed. |
| Root cause | Other |
| Action | The recalling firm sent a recall letter, dated 3/15/05 to their consignee. |
| Quantity | 2600 units. |
| Distribution | The recalling firm distributed the product to one consignee (distributor): North Coast Medical Inc., 18305 Sutter Blvd., Morgan Hill, CA 95037. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031053 | SELECTIVE MED COMPONENTS, INC. BUFFERED IONTOPHORESIS DRUG DELIVERY SYSTEM ELECTRODES, MODELS I20, I30, I40, I50, AND I7 Selectivemed Components, Inc., May 20, 2003 |