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Gynex Corporation recalls Sterile, single-use, disposable electrosurgical electrode holder. It connects the electrode to the foot activated elect
Recalled October 10, 2012 · FDA recall Z-0008-2013 · Gynex
Hazard
The wrong electrical connector pin was attached to the cord during assembly by the manufacturer. this electrical connector is too big to fit into the port on the foot activated generator. this makes the device unusable. · FDA Class III
Units
19 boxes (containing 12 electorde hand pieces each)
Sold at
Nationwide Distribution
Description
The wrong electrical connector pin was attached to the cord during assembly by the manufacturer. this electrical connector is too big to fit into the port on the foot activated generator. this makes the device unusable.
Product
Sterile, single-use, disposable electrosurgical electrode holder. It connects the electrode to the foot activated electric generator. Label reads in part "***GYNEX*** Electrode Handpiece, Foot Activated*** Manufactured for GYNEX***" Gynex catalog number: 950 (Gynex REF 950, Electrode Handpiece) It connects the electrode to the food activated electric generator. Electrodes are used in gynecological procedures, in a physician's office, for cutting to remove tissue and coagulation to control bleeding by the use of high frequency current.
Manufacturer(s)
Gynex Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →