Iontophoresis active electrode, small, 1.5cc capacity, sold as Model # NC89250B. Product is packaged in 12 treatment kit
FDA device recall Z-0799-05 · posted 2005-05-06 · Terminated
Recall details
- Recalling firm
- Selectivemed Components Inc
- Reason for recall
- The conductor portion of the electrode is installed backwards, with the plastic and silver portions of the electrode reversed.
- Action taken
- The recalling firm sent a recall letter, dated 3/15/05 to their consignee.
- Root cause
- Other
- Status
- Terminated
- Product code
- EGJ
- Quantity affected
- 2600 units.
- Distribution
- The recalling firm distributed the product to one consignee (distributor): North Coast Medical Inc., 18305 Sutter Blvd., Morgan Hill, CA 95037.
- Date initiated
- 2005-03-15
- Date posted
- 2005-05-06
- Date terminated
- 2007-07-21
- Location
- Mount Vernon, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SELECTIVE MED COMPONENTS, INC. BUFFERED IONTOPHORESIS DRUG DELIVERY SYSTEM ELECTRODES, MODELS I20, I30, I40, I50, AND I7 (K031053) | Selectivemed Components, Inc. | 2003-05-20 |