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U.S. Department of Health and Human Services

Class 2 Device Recall Iontophoresis active electrode

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  Class 2 Device Recall Iontophoresis active electrode see related information
Date Initiated by Firm March 15, 2005
Date Posted May 06, 2005
Recall Status1 Terminated 3 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
Recalling Firm/
Selectivemed Components Inc
564 Harcourt Rd
Mount Vernon OH 43050-3920
For Additional Information Contact Spence Badet
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 2
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 and Original Applicant = SELECTIVE MED COMPONENTS, INC.