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Terminated

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.

FDA Recall Z-0799-05 · Posted 2005-05-06

Recalling FirmSelectivemed Components Inc
Recall StatusTerminated
Product CodeEGJ
Date Initiated2005-03-15
Date Terminated2007-07-21
Product Quantity2600 units.

Reason for Recall

The conductor portion of the electrode is installed backwards, with the plastic and silver portions of the electrode reversed.

Firm Action

The recalling firm sent a recall letter, dated 3/15/05 to their consignee.

Root Cause

Other

Distribution Pattern

The recalling firm distributed the product to one consignee (distributor): North Coast Medical Inc., 18305 Sutter Blvd., Morgan Hill, CA 95037.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K031053SELECTIVE MED COMPONENTS, INC. BUFFERED IONTOPHORESIS DRUG DELIVERY SYSTEM ELECTRODES, MODELS I20, I30, I40, I50, AND I7Selectivemed Components, Inc. · 2003-05-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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