Skip to content
Recall Observatory FDA recall evidence

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

July 10, 2013

Class II

Product summary

Firm
Precision Dynamics Corporation
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

    reason.labeling_packaging · v1.0.0

    mislabeled