FDA Medical Device Recalls (openFDA)
Valleylab, Inc: Radionics Cool-Tip RF Electrode Kit, containing DGP-HP single-use grounding pads.
- Recall number
- Z-1122-03
- Recalling firm
- Valleylab, Inc
- Product
- Radionics Cool-Tip RF Electrode Kit, containing DGP-HP single-use grounding pads.
- Status
- Terminated
- Initiated
- 2003-07-16
- Posted
- 2003-08-12
- Terminated
- 2004-02-18
- 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.
- Lot, serial or model codes
- Catalog Numbers: CT-1020, CT-1030, CT-1510, CT-1520, CT-1530, CT-2020, CT-2030, CT-2530, CTC-1025, CTC-1525, CTC-2025.
- 510(k) numbers
- ["K000079"]
- PMA numbers
- not on file
- Product code
- HAM
- Firm FEI
- 1717344
- Firm city
- Boulder
- Firm state
- CO
- 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