PSC Industries Inc: Medical Device Recall in 2012 - (Recall #: Z-1991-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: June 5, 2012

Date Posted: July 18, 2012

Recall Number: Z-1991-2012

Event ID: 62332

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.

Status: Terminated

Product Quantity: 725 units (125=Lot #023392 & 600 units Lot #022438)

Code Information:

Model Number: 75800, Lot Numbers: 023392 and 022438

Distribution Pattern:

Nationwide Distribution-including DC and the states of CA, GA, IN, KY, LA, MT, TX, UT, and WI.

Voluntary or Mandated:

Voluntary: Firm initiated