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U.S. Department of Health and Human Services

Enforcement Report - Week of August 14, 2013

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Product Detail

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.
Recall Number Z-1872-2013
Classification Class II
Code Info Part Number: PDC PN STERVIS (Viscot PN 1437-100) Lot: 061313.
Product Distributed Qty 1,200 pens
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.

Event Detail

Event Id 65724
Product Type Devices
Status Ongoing
Recalling Firm Precision Dynamics Corporation
City Valencia
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-07-10
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern US Distribution including the states of SC, TX, TN, WA, OK.