Z-1990-2012 Class II Terminated
FDA device recall Z-1990-2012 was initiated by PSC Industries Inc on June 5, 2012 and is designated Class II. 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… The recall status is terminated (terminated January 17, 2014). Affected quantity: 50 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 18, 2012
- Initiation Date
- June 5, 2012
- Termination Date
- January 17, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 50 units
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.
Distribution Pattern
Nationwide Distribution-including DC and the states of CA, GA, IN, KY, LA, MT, TX, UT, and WI.
Code Information
Model Number: 75820, Lot Number: 019632