Enforcement Report - Week of July 18, 2012
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Product Detail
| Product Description | Button Switchpens, w/Extendable Needle Electrode 10 mm Exposure, Single Use device, Electrosurgical./Extendable Pencils, 510(k)#K936304, Model Number: 75800. The device is packaged in a sterile Tyvek peel pouch within a cardboard box. The cartons contain 25 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. |
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| Recall Number | Z-1991-2012 |
| Classification | Class II |
| Code Info | Model Number: 75800, Lot Numbers: 023392 and 022438 |
| Product Distributed Qty | 725 units (125=Lot #023392 & 600 units Lot #022438) |
| Reason For Recall | The Tyvek pouch label for this device states: 'with holster'; however, this product does not come with a holster. Firm officials met with FDA on 5/17/2012. At which time, they reported various labeling errors with 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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