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DGPHP RFA High-Power Single Use Grounding Pads and Cool-Tip… recallZ-2301-2012 · Nellcor Puritan Bennett Inc. (dba Covidien LP) · initiated Aug 1, 2012

Class II Terminated All recalls posted in August 2012

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Nellcor Puritan Bennett Inc. (dba Covidien LP) or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Process control

What the company is doing

The firm, Covidien, sent an "URGENT MEDICAL DEVICE RECALL" letter dated August 6, 2012, to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately quarantine and discontinue use of the device; immediately advise all DGPHP RFA High-Power single use grounding pads and Cool-tip RF Electrode kit users of this recall; complete and return the attached Recalled Product Return Form in its entirety via fax to (800) 895-6140; return affected product to Covidien Attn: Field Returns Department, 195 McDermott Road, North Haven, CT 06473; if purchased directly from Covidien include completed form via fax or by email to : [email protected]; if purchased from distributor complete form and contact your Distributor directly (completed form and all affected units must be returned through the Distributor); and reply to Covidien WHETHER OR NOT you have affect product at your site. If you have any questions or concerns, please do not hesitate to contact your Covidien representative or Quality Assurance, Monday through Friday, 8:30-5:00, directly at 203-492-5232.

Recall details

Recall number
Z-2301-2012
Recall class
Class II
Status
Terminated
Initiated by the company
Aug 1, 2012
Posted by the FDA
Aug 29, 2012
Recalling firm
Nellcor Puritan Bennett Inc. (dba Covidien LP)
Quantity
184,934 units
Product code
GEI
FDA submissions
K030697, K973297
Distribution
Worldwide distribution: USA (nationwide) and countries including: Australia, Brazil, Canada, Columbia, Deutchland, France, Japan, Mexico, Panama, Puerto Rico, Singapore, and Uruguay.

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.

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

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.

Other devices under the same FDA submission

4 devices cleared under K030697, K973297 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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