Recall Z-1122-03 ยท HAM Apparatus, Electrosurgical
Valleylab, Inc
Radionics Cool-Tip RF Electrode Kit, containing DGP-HP single-use grounding pads.
| Date | Aug 12, 2003 (initiated Jul 16, 2003) |
| Status | Terminated |
| Reason | Pads may have a thin plastic film covering the conductive gel surface underneath the normal printed cover, causing non-adherence and possible burn. |
| Root cause | Other |
| Action | Users were notified by letter on 7/16/2003. |
| Quantity | 10,000 kits |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K000079 | NIKOPAD ELECTROSURGICAL GROUNDING PAD, MODEL 4777M Nikomed U.S.A., Inc., Feb 4, 2000 |