Enforcement Report - Week of October 10, 2012
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Product Detail
| 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. |
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| Recall Number | Z-0008-2013 |
| Classification | Class III |
| Code Info | Manufacturer's lot number: 54-12-2-21-12. |
| Product Distributed Qty | 19 boxes (containing 12 electorde hand pieces each) |
| 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. |
Event Detail
| Event Id | 63253 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Gynex Corporation |
| City | Redmond |
| State | WA | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-09-06 |
| Initial Firm Notification of Consignee or Public | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Distribution Pattern | Nationwide Distribution |
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