FDAFDA · Food and drugs·Recall number Z-1872-2013
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.
Published August 14, 2013 · Recall initiated: July 10, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Precision Dynamics Corporation
- Distributor
- US Distribution including the states of SC, TX, TN, WA, OK.
- Lot
- Part Number: PDC PN STE-VIS (Viscot PN 1437-100) Lot: 061313.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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