The Recall Desk
LowFDA (Devices)·Z-1990-2012·Announced 2012-07-18

PSC Industries Recalls Button Switch Pen Electrodes Due to Labeling Errors

PSC Industries is recalling 50 units of Button Switch Pen Electrodes due to a labeling error where the manufacturer symbol replaced the expiration date symbol.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is for a documentation and labeling issue (incorrect symbol placement) with no reported injuries or illnesses, fitting the criteria for a Low severity recall.

Plain-English summary

PSC Industries Inc is recalling 50 units of Button Switch Pen Electrodes, Model Number 75820, Lot Number 019632. These single-use electrosurgical devices are used for coagulating and cutting tissue during surgical procedures. The recall is limited to units distributed nationwide, including DC and the states of CA, GA, IN, KY, LA, MT, TX, UT, and WI.

The recall was initiated because the carton label for the device incorrectly displays the manufacturer symbol in the location where the expiration date symbol should be. Firm officials met with the FDA on May 17, 2012, to report various labeling errors associated with these products.

Healthcare facilities and distributors should stop using these specific units and contact PSC Industries for instructions on how to return or dispose of the affected products.

The recalled product

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 an
Manufacturer
PSC Industries Inc
Affected units
50

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Model Number: 75820
  • Lot Number: 019632

Distribution

Distributed nationwide across the United States.

The notice also names 10 states specifically:

Part of a larger recall action

This product is one of 2 recalled by PSC Industries Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →