Z-1122-03

Radionics Cool-Tip RF Electrode Kit, containing DGP-HP single-use grounding pads

Name: Z-1122-03 Radionics Cool-Tip RF Electrode Kit, containing DGP-HP single-use grounding pads
Creator: Valleylab, Inc
Published: 2003-07-16
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2003-07-16 / Terminated

FDA source

Valleylab, Inc began a recall of Radionics Cool-Tip RF Electrode Kit, containing DGP-HP single-use grounding pads on 2003-07-16. The reason FDA records is "Pads may have a thin plastic film covering the conductive gel surface underneath the normal printed cover, causing non-adherence and possible burn". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1122-03
Status: Terminated
Initiated: 2003-07-16
Posted: 2003-08-12
Terminated: 2004-02-18
Recalling firm: Medtronic, Inc.
Product: Radionics Cool-Tip RF Electrode Kit, containing DGP-HP single-use grounding pads.
Product code: HAM Apparatus, Electrosurgical
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.
FDA root cause: Other
Action: Users were notified by letter on 7/16/2003.
Quantity in commerce: 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.
Product codes and lots: Catalog Numbers: CT-1020, CT-1030, CT-1510, CT-1520, CT-1530, CT-2020, CT-2030, CT-2530, CTC-1025, CTC-1525, CTC-2025.

Product code HAM

K000079Class IINikopad Electrosurgical Grounding Pad, Model 4777MNikomed U.S.A., Inc. / cleared 2000-02-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)