Device product
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.
Z-1872-2013
Product summary
- Event
- Event 65724
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,200 pens
- Official record key
device-enforcement:Z-1872-2013
Official wording
Reason: 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.
Code information: Part Number: PDC PN STE-VIS (Viscot PN 1437-100) Lot: 061313.
Distribution pattern: US Distribution including the states of SC, TX, TN, WA, OK.
Derived failure modes
-
Labeling or packaging
mislabeled