Z-1872-2013 Class II Terminated

Recalled by Precision Dynamics Corporation — Valencia, CA

Recall Details

Product Type
Devices
Report Date
August 14, 2013
Initiation Date
July 10, 2013
Termination Date
January 6, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,200 pens

Product Description

Non-sterile Viscot Surgical Skin Markers Part Number 1437-100 Non-sterile Viscot Part Number 143-100 Surgical Skin Markers are pen-like devices intended to be used to write on the patient's skin, e.g., to outline surgical incision sites or mark anatomical sites for accurate blood pressure measurement; available in nonsterile configuration.

Reason for Recall

PDC Healthcare initiated this recall of Non-Sterile Viscot Part Number 1437-100 Surgical Skin Markers, becuase they were inadvertently mislabeled as PN STER-VIS Sterile Skin Marker Pen with Labels and Flex Ruter.

Distribution Pattern

US Distribution including the states of SC, TX, TN, WA, OK.

Code Information

Part Number: PDC PN STE-VIS (Viscot PN 1437-100) Lot: 061313.