Z-0008-2013 Class III Terminated
FDA device recall Z-0008-2013 was initiated by Gynex Corporation on September 6, 2012 and is designated Class III. Reason for recall: 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 recall status is terminated (terminated October 22, 2012). Affected quantity: 19 boxes (containing 12 electorde hand pieces each).
Recall Details
- Product Type
- Devices
- Report Date
- October 10, 2012
- Initiation Date
- September 6, 2012
- Termination Date
- October 22, 2012
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 19 boxes (containing 12 electorde hand pieces each)
Product Description
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.
Reason for Recall
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.
Distribution Pattern
Nationwide Distribution
Code Information
Manufacturer's lot number: 54-12-2-21-12.