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.
Recall
- Recall Number
- Z-1991-2012
- Event Number
- 62332
- Firm
- PSC Industries Inc
- FEI Number
- 3000719969
- Product Code
- GEI
- Status
- Terminated
- Root Cause
- Labeling mix-ups
- Initiated
- June 5, 2012
- Posted
- July 11, 2012
- Terminated
- January 17, 2014
- Address
- 3230 Commerce Center Pl, Louisville, KY, 40211-1900
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.
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.
Olsen Medical sent an "URGENT:MEDICAL DEVICE RECALL" letter dated June 5, 2012. The letter identifies the product, problem, and actions to be taken by the customers. The letter asks that the customer immediately examine their inventory for the presence of the suspect product and quarantine the product, if found. Customers who may have further distributed the recalled product are asked to contact their (sub-account) customers and notify them of the recall. The customers are also asked to call a toll-free telephone number in order to received a Return Material Authorization (RMA) number and so identify if they would like credit or replacement inventory upon returning the product. The customer is also asked to complete and return the enclosed 'Recall Response Form' and to fax the completed form to the fax number on the form or to send the completed from back to the recalling firm via parcel post.
Nationwide Distribution-including DC and the states of CA, GA, IN, KY, LA, MT, TX, UT, and WI.
725 units (125=Lot #023392 & 600 units Lot #022438)