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Covidien Initiates a Voluntary Recall of DGPHP RFA High-Power Single Use Grounding Pads and Cool-tip™ RFA Electrode Kits that Contain DGPHP RFA High-Power Single Use Grounding Pads

Published on Friday, 17 August 2012 17:31

FG_AUTHORS: FDA

Recall -- Firm Press Release

 

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

 

Covidien Initiates a Voluntary Recall of DGPHP RFA High-Power Single Use
Grounding Pads and Cool-tip™ RFA Electrode Kits that Contain DGPHP RFA High-Power
Single Use Grounding Pads

 

 

Contact:
Consumer:
1-800-722-8772

 

FOR IMMEDIATE RELEASE - August 17, 2012 - Covidien today announced that it is conducting a voluntary recall of certain production lots of the DGPHP RFA high-power single use grounding pads and Cool-tip™ RFA electrode kits that contain DGPHP RFA high-power single use grounding pads.

Covidien has voluntarily decided to recall specific lots manufactured prior to August 30, 2011, due to the potential degradation of foil within the DGPHP grounding pad. Covidien has received reports of four serious injuries, burns at the pad site on the patient, which may be related to this product quality issue.
 

The affected product descriptions and lots are as follows:

 

 

Product
Code

 

Lot Number Ranges*:

ACTC1525

168575

through

215632

ACTC2025

168853

through

213703X

SWCT1530

170383

through

213699X

SWCT15303

169683

through

213042X

SWCT1540

170384

through

215746X

SWCT2530

184240

through

205456

SWCT25303

177906

through

214357X

SWCT2540

191404

through

205455

DGPHP

162732

through

214867X

 

 

Product
Code

 

Lot Number Ranges*:

ACT1020

168583

through

213736X

ACT1030

171281

through

215747X

ACT1507

168576

through

214355X

ACT1510

170882

through

214971X

ACT1520

168571

through

213013X

ACT1530

169419

through

220740

ACT2020

168854

through

213368X

ACT2030

168574

through

214434X

ACT2530

169684

through

214973

ACTC1025

171300

through

208194X

* Lot Numbers may contain a suffix “X” 

 

Covidien is working with the United States Food and Drug Administration (FDA) and other regulatory authorities on this voluntary recall.

Customers have been notified of this recall by letter on August 6, 2012. Please return the affected product by contacting Customer Service at SDFeedback@Covidien.com or 1-800-722-8772, option 1, to obtain a Return Goods Authorization prior to returning the affected units.

Healthcare professionals and customers may report adverse events or quality problems experienced with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online, by phone or by fax.

·    Online: www.fda.gov/medwatch/report.htm
·    Phone:  1-800-332-1088
·    Fax:        1-800-332-0178


 

 

 

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