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U.S. Department of Health and Human Services

Enforcement Report - Week of September 5, 2012

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Product Detail

Product Description 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.
Recall Number Z-2301-2012
Classification Class II
Code Info 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,
Product Distributed Qty 184,934 units
Reason For Recall 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.

Event Detail

Event Id 62705
Product Type Devices
Status Ongoing
Recalling Firm Nellcor Puritan Bennett Inc. (dba Covidien LP)
City Boulder
State CO
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-08-01
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide distribution: USA (nationwide) and countries including: Australia, Brazil, Canada, Columbia, Deutchland, France, Japan, Mexico, Panama, Puerto Rico, Singapore, and Uruguay.