FDA-Device2013-08-14Class II
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.
Precision Dynamics Corporation
Hazard
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.
Sold states
US Distribution including the states of SC, TX, TN, WA, OK.
Affected count
1,200 pens
Manufactured in
27770 Entertainment Dr, Suite 200, Valencia, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1872-2013Don't want to check this manually?
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