Conmed Pediatric Dual Dispersive Electrodes Recalled for Burn Risk
Conmed is recalling 4,560 pediatric dual dispersive electrodes because they may be incompatible with some generators, risking 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (potential burn) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Conmed Corporation is recalling 4,560 units of Pediatric Dual Dispersive Electrodes (Catalog Number 7-383) for patients weighing 5-15 kg. These electrodes are intended for use with the Birtcher Pad Sensing System on specific Birtcher and CONMED electrosurgical generators or conventional units with similar contact monitoring systems.
The recall was initiated because a version of the dual dispersive electrodes may not be compatible with some electrosurgical generators. This incompatibility places patients at risk for undetected pad lift, which can lead to a potential burn. The affected units were distributed worldwide, including the United States and various international markets.
Healthcare facilities and users should stop using the affected electrodes and contact Conmed Corporation for further instructions on the recall.
The recalled product
- Product
- Pediatric Dual Dispersive Electrodes (for patients 5-15 kg.), use with the Birtcher Pad Sensing System (PSS) on the Birtcher Systems 6000, 6400, 6500 and CONMED Systems 7500 and 7550 ABC¿ generators or conventional electrosurgery units with similar contact monitoring systems…
- Manufacturer
- Conmed Corporation
- Affected units
- 4,560
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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