Reported Sep 5, 2012 · Terminated

DGPHP RFA High-Power Single Use Grounding Pads and Cool-Tip RFA Electrode Kits (containing DGPHP RFA High-Power single…

Nellcor Puritan Bennett Inc. (dba Covidien LP)

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Nellcor Puritan Bennett Inc. (dba Covidien LP) · 6135 Gunbarrel Ave · Boulder, CO · 80301-3214

Is this the product you have?

  • 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.
Lot codes and dates

20 of 20 products

Products covered by this recall
#Product as published
1ACT1020, 168583 through , 210055X
2ACTC1525, 168575 through, 208115X
3ACT1030, 171291 through , 209598X
4ACTC2025, 168853 through, 209457X
5ACT1507, 168576 through, 209455X
6SWCT1530, 170383 through, 210057X
7ACT1510, 170882 through , 207901X
8SWCT15303, 169683 through, 207900X
9ACT1520, 168571 through, 210054X
10SWCT1540, 170384 through, 197330
11ACT1530, 169419 through, 209547X
12SWCT20303, 191407 through, 191407
13ACT2020, 168854 through, 210720X
14SWCT2303, 195745 through, 195745
15ACT2030, 168574 through, 209453X
16SWCT2530, 205456 through, 205456
17ACT2530, 169684 through, 209599X
18SWCT25303, 177906 through, 213729X
19ACTC1025, 171300 through, 208194X
20SWCT2540, 191404 through, 205455, , , , DGPHP, 162732 through, 214867X
Amount recalled
184,934 units

Where it was sold

  • Nationwide
  • PR

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Sep 6, 2013 · Data as of Sep 19, 5:24 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.