Reported Aug 31, 2016 · Terminated
Adult Dual Dispersive Electrodes (for patients >15 kg.), use with the Birtcher Pad Sensing System (PSS) on the Birtcher…
Conmed Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Conmed Corporation · 310 Broad St · Utica, NY · 13501-1203
Is this the product you have?
- Adult Dual Dispersive Electrodes (for patients >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, 10' (3.05m) Cable, Catalog Number 7-382. Intended to be used for the dispersion and return to the electrosurgical generator.
- Lot codes and dates
- Beginning Lot Code 141001X with Ending Lot Code 20150705X.
- Amount recalled
- 124,333 units
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
Why it was recalled
A version of the dual dispersive electrodes may not be compatible with some electrosurgical generators, placing patients at risk for undetected pad lift and a potential burn.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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