Cloth electrodes with Carbon construction: P/N 201-1231, Cat Nos.: 201-123, 202-454, 203-118, 203-342, 203-454, 203-493,
FDA device recall Z-0815-2013 · posted 2013-02-14 · Terminated
Recall details
- Recalling firm
- NAImco Inc dba Richmar Inc
- Reason for recall
- Electrode Socket Terminal pulling away from the electrode lead wire when the electrical stim lead wire was removed.
- Action taken
- Rich-Mar sent "URGENT: MEDICAL DEVICE VOLUNTARY RECALL" letters to affected customers beginning on 11/30/2009. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at 423-648-7730 ext. 214 for questions relating to t his recall.
- Root cause
- Unknown/Undetermined by firm
- Status
- Terminated
- Product code
- GXY
- Quantity affected
- 209860 electrodes
- Distribution
- Distributed in the states of GA and TN.
- Date initiated
- 2009-11-30
- Date posted
- 2013-02-14
- Date terminated
- 2013-09-03
- Location
- Chattanooga, TN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EZ-STIK ELECTRODES (K050469) | Naimco, Inc. | 2005-05-13 |