FDA Device recall Z-2301-2012
DGPHP RFA High-Power Single Use Grounding Pads and Cool-Tip RFA Electrode Kits (containing DGPHP RFA High-Power single use grounding pads)…
- FDA Device
- Class II
- terminated
- Published 2012-09-05
On 2012-09-05 the FDA classified a Class II recall of DGPHP RFA High-Power Single Use Grounding Pads and Cool-Tip RFA Electrode Kits (containing DGPHP RFA High-Power single use grounding pads)… by Nellcor Puritan Bennett Dba Covidien, citing covidien is conducting a recall of various production lots of DGHP RFA High Power single use grounding pads and Cool-tip RFA Electrode Kits due to the potential for foil degradati….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2301-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-08-01 |
| Published | 2012-09-05 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Nellcor Puritan Bennett Dba Covidien |
| Distribution | US |
Product
DGPHP RFA High-Power Single Use Grounding Pads and Cool-Tip RFA Electrode Kits (containing DGPHP RFA High-Power single use grounding pads) The product is used during ablation surgical procedures.
Reason
Covidien is conducting a recall of various production lots of DGHP RFA High Power single use grounding pads and Cool-tip RFA Electrode Kits due to the potential for foil degradation on the DGP-HP single use grounding pad which may result in an electrical burn to the patient at the application site.
Identifiers
| code_info | ACT1020, 168583 through , 210055X; ACTC1525, 168575 through, 208115X; ACT1030, 171291 through , 209598X; ACTC2025, 1688…ACT1020, 168583 through , 210055X; ACTC1525, 168575 through, 208115X; ACT1030, 171291 through , 209598X; ACTC2025, 168853 through, 209457X; ACT1507, 168576 through, 209455X; SWCT1530, 170383 through, 210057X; ACT1510, 170882 through , 207901X; SWCT15303, 169683 through, 207900X; ACT1520, 168571 through, 210054X; SWCT1540, 170384 through, 197330; ACT1530, 169419 through, 209547X; SWCT20303, 191407 through, 191407; ACT2020, 168854 through, 210720X; SWCT2303, 195745 through, 195745; ACT2030, 168574 through, 209453X; SWCT2530, 205456 through, 205456; ACT2530, 169684 through, 209599X; SWCT25303, 177906 through, 213729X; ACTC1025, 171300 through, 208194X; SWCT2540, 191404 through, 205455, , , , DGPHP, 162732 through, 214867X, |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2301-2012%22
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