Class 2 Device Recall Iontophoresis active electrode

• Date Initiated by Firm: March 15, 2005
• Date Posted: May 06, 2005
• Recall Status: Terminated on July 21, 2007
• Recall Number: Z-0799-05
• Recall Event ID: 31453
• 510(K)Number: K031053
• Product Classification: Device, Iontophoresis, Other Uses - Product Code EGJ
• Product: 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.
• Code Information: Lot #251478-003
• FEI Number: 1000136007
• Recalling Firm/ Manufacturer: Selectivemed Components Inc; 564 Harcourt Rd; Mount Vernon OH 43050-3920
• For Additional Information Contact: Spence Badet; 800-621-3425
• Manufacturer Reason for Recall: The conductor portion of the electrode is installed backwards, with the plastic and silver portions of the electrode reversed.
• FDA Determined Cause: Other
• Action: The recalling firm sent a recall letter, dated 3/15/05 to their consignee.
• Quantity in Commerce: 2600 units.
• Distribution: The recalling firm distributed the product to one consignee (distributor): North Coast Medical Inc., 18305 Sutter Blvd., Morgan Hill, CA 95037.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = EGJ