Conmed Pediatric ThermoGard Electrodes Recalled for Burn Risk
Conmed is recalling Pediatric ThermoGard Dual Dispersive Electrodes because they may be incompatible with some electrosurgical generators, posing a risk of undetected pad lift and potential burns.
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 defect that poses a risk of burns to patients. According to the rubric, significant injury reports or risks associated with medical devices typically warrant a Severe (4) classification, especially given the potential for physical harm during surgery.
Plain-English summary
Conmed Corporation is recalling 6,640 units of Pediatric ThermoGard Dual Dispersive Electrodes (Catalog Number 51-7710) intended for patients weighing 5-15 kg. The affected units feature a 10-foot (3.05m) cable and are identified by lot codes ranging from 141001X to 20150705X.
The recall was initiated because a version of these dual dispersive electrodes may not be compatible with certain electrosurgical generators. This incompatibility can result in undetected pad lift, which places patients at risk for potential burns during electrosurgical procedures.
The affected products were distributed worldwide, including in the United States (all states and Puerto Rico) and in numerous international markets such as Australia, Canada, China, France, Japan, and the United Kingdom. Healthcare facilities and distributors should stop using the affected units and contact Conmed Corporation for further instructions on the recall.
The recalled product
- Product
- Pediatric ThermoGard¿ Dual Dispersive Electrodes (for patients 5-15 kg.), 10' (3.05m) Cable, Catalog Number 51-7710. Intended to be used for the dispersion and return to the electrosurgical generator.
- Manufacturer
- Conmed Corporation
- Affected units
- 6,640
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 (1)
- Beginning Lot Code 141001X with Ending Lot Code 20150705X.
Distribution
Part of a larger recall action
This product is one of 5 recalled by Conmed Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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