Reported Oct 10, 2012 · Terminated
Sterile, single-use, disposable electrosurgical electrode holder. It connects the electrode to the foot activated…
Gynex Corporation
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.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: Gynex Corporation · 14603 NE 87th St. · Redmond, WA · 98052
Is this the product you have?
- 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 number950 (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
- Lot codes and dates
- Manufacturer's lot number54-12-2-21-12
- Amount recalled
- 19 boxes (containing 12 electorde hand pieces each)
Where it was sold
- Nationwide
Why it was recalled
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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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