Radionics Disposable Grounding Plate
FDA device recall Z-1121-03 · posted 2003-08-12 · Terminated
Recall details
- Recalling firm
- Valleylab, Inc
- Reason for recall
- Pads may have a thin plastic film covering the conductive gel surface underneath the normal printed cover, causing non-adherence and possible burn.
- Action taken
- Users were notified by letter on 7/16/2003.
- Root cause
- Other
- Status
- Terminated
- Product code
- HAM
- Quantity affected
- 25000 pads
- Distribution
- Nationwide. VA Hospital, San Antonio, TX. Foreign distribution to Australia, Brazil, Canada, Dominican Republic, France, Germany, Hong Kong, India, Israel, Japan, Korea, Phillipines, Singapore, Taiwan
- Date initiated
- 2003-07-16
- Date posted
- 2003-08-12
- Date terminated
- 2004-02-18
- Location
- Boulder, CO
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NIKOPAD ELECTROSURGICAL GROUNDING PAD, MODEL 4777M (K000079) | Nikomed U.S.A., Inc. | 2000-02-04 |