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