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Class 2 Device Recall Iontophoresis active electrode |
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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
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Product Classification |
Device, Iontophoresis, Other Uses - Product Code EGJ
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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/ Manufacturer |
Selectivemed Components Inc 564 Harcourt Rd Mount Vernon OH 43050-3920
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For Additional Information Contact |
Spence Badet 800-621-3425
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Manufacturer Reason for Recall |
The conductor portion of the electrode is installed backwards, with the plastic and silver portions of the electrode reversed.
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FDA Determined Cause 2 |
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
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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.
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510(K) Database |
510(K)s with Product Code = EGJ and Original Applicant = SELECTIVE MED COMPONENTS, INC.
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