Z-1872-2013 Class II Terminated
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.