Agency classClass IIOur severity:Severe FDA (Devices)·Z-2301-2012·Announced 2012-09-05

Recall of DGHP RFA High-Power Grounding Pads Due to Burn Risk

Nellcor Puritan Bennett Inc. is recalling DGHP RFA High-Power grounding pads and electrode kits because foil degradation may cause electrical burns to patients.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a medical device with a potential for electrical burns to patients, which constitutes a significant injury risk under the rubric for Severe recalls.

Plain-English summary

Nellcor Puritan Bennett Inc. (dba Covidien LP) is recalling various production lots of DGHP RFA High-Power single use grounding pads and Cool-tip RFA Electrode Kits. The recall is 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.

The affected products are used during ablation surgical procedures. The recall covers 184,934 units distributed worldwide, including the United States (nationwide) and countries such as Australia, Brazil, Canada, Columbia, Deutchland, France, Japan, Mexico, Panama, Puerto Rico, Singapore, and Uruguay.

The source text does not specify specific actions for consumers or healthcare providers beyond the recall notice itself.

The recalled product

Product: 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.
Manufacturer: Nellcor Puritan Bennett Inc. (dba Covidien LP)
Category: Medical Device — Surgical Equipment
Hazard: burn-injury
Affected units: 184,934

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

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

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Same manufacturer · Nellcor Puritan Bennett Inc. (dba Covidien LP)

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