Recall Z-1990-2012 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
PSC Industries Inc
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
| Date | Jul 11, 2012 (initiated Jun 5, 2012) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Labeling mix-ups |
| Action | 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 s |
| Quantity | 50 units |
| Distribution | Nationwide Distribution-including DC and the states of CA, GA, IN, KY, LA, MT, TX, UT, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K936304 | ELECTROSURGICAL PENCIL E & M Engineering, Inc., Jun 13, 1994 |