FDA Medical Device Recalls (openFDA)
Selectivemed Components Inc: 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.
- Recall number
- Z-0799-05
- Recalling firm
- Selectivemed Components Inc
- 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.
- Status
- Terminated
- Initiated
- 2005-03-15
- Posted
- 2005-05-06
- Terminated
- 2007-07-21
- Reason
- The conductor portion of the electrode is installed backwards, with the plastic and silver portions of the electrode reversed.
- Root cause
- Other
- Action
- The recalling firm sent a recall letter, dated 3/15/05 to their consignee.
- Quantity
- 2600 units.
- Distribution
- The recalling firm distributed the product to one consignee (distributor): North Coast Medical Inc., 18305 Sutter Blvd., Morgan Hill, CA 95037.
- Lot, serial or model codes
- Lot #251478-003
- 510(k) numbers
- ["K031053"]
- PMA numbers
- not on file
- Product code
- EGJ
- Firm FEI
- 1000136007
- Firm city
- Mount Vernon
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28