Z-0799-05

Iontophoresis active electrode, small, 1.5cc capacity, sold as Model # NC89250B. Product is packaged in 12...

Name: Z-0799-05 Iontophoresis active electrode, small, 1.5cc capacity, sold as Model # NC89250B. Product is packaged in 12...
Creator: Selectivemed Components Inc
Published: 2005-03-15
License: https://open.fda.gov/license/

Spectramed, LLC / initiated 2005-03-15 / Terminated

FDA source

Selectivemed Components Inc began a recall of Iontophoresis active electrode, small, 1.5cc capacity, sold as Model # NC89250B. Product is packaged in 12 treatment kit box labeled as Buffered Iontophoretic... on 2005-03-15. The reason FDA records is "The conductor portion of the electrode is installed backwards, with the plastic and silver portions of the electrode reversed". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0799-05
Status: Terminated
Initiated: 2005-03-15
Posted: 2005-05-06
Terminated: 2007-07-21
Recalling firm: Spectramed, LLC
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.
Product code: EGJ Device, Iontophoresis, Other Uses
Reason for recall: The conductor portion of the electrode is installed backwards, with the plastic and silver portions of the electrode reversed.
FDA root 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.
Product codes and lots: Lot #251478-003

Product code EGJ

K031053Class IISelective Med Components, Inc. Buffered Iontophoresis Drug Delivery System Electrodes, Models I20, I30, I40, I50, and I7Selectivemed Components, Inc. / cleared 2003-05-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)