Enforcement Report - Week of July 18, 2012
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Product Detail
| Product Description | Button Switchpens, w/Extendable Needle Electrode 2 mm Exposure Single Use Electrosurgical./Extendable Pencils, 510(k) #K936304, Model Number: 75820. The device is packaged in a sterile Tyvek peel pouch within a cardboard box which contains 24 pouches per box. Pens/Pencils and Handles -- Olsen Medical Pens/Pencils and handles are designed to hold active electrodes Single Use device intended for coagulating and cutting tissue during surgical procedures. |
|---|---|
| Recall Number | Z-1990-2012 |
| Classification | Class II |
| Code Info | Model Number: 75820, Lot Number: 019632 |
| Product Distributed Qty | 50 units |
| Reason For Recall | The carton label for this device has the manufacturer symbol where the expiration date symbol should be. Firm officials met with FDA on 5/17/2012. At which time, they reported various labeling errors for their Button Switch Pen Electrode Electrosurgical /Extendable Pencils. |
Event Detail
| Event Id | 62332 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | PSC Industries Inc |
| City | Louisville |
| State | KY | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-06-05 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Nationwide Distribution-including DC and the states of CA, GA, IN, KY, LA, MT, TX, UT, and WI. |
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