Z-1991-2012 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 18, 2012
- Initiation Date
- June 5, 2012
- Termination Date
- January 17, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 725 units (125=Lot #023392 & 600 units Lot #022438)
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.
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.
Distribution Pattern
Nationwide Distribution-including DC and the states of CA, GA, IN, KY, LA, MT, TX, UT, and WI.
Code Information
Model Number: 75800, Lot Numbers: 023392 and 022438