Recall Z-1990-2012— PSC Industries Inc

Name: FDA recall Z-1990-2012
Creator: U.S. Food and Drug Administration
Published: 2012-06-05

Class II · Terminated

Class II FDA medical device recall by PSC Industries Inc, initiated 2012-06-05, terminated 2014-01-17. It names one FDA 510(k) clearance: K936304. Product: 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.. 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..

Recalling firm: PSC Industries Inc
Classification: Class II
Status: Terminated
Initiated: 2012-06-05
Terminated: 2014-01-17
Firm location: Louisville, KY, United States

510(k) clearances named in this recall

1 on FDA's record

K936304 — ELECTROSURGICAL PENCILE & M Engineering, Inc.·cleared 1994-06-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.