Recall Z-1872-2013— Precision Dynamics Corporation
Class II · Terminated
Class II FDA medical device recall by Precision Dynamics Corporation, initiated 2013-07-10, terminated 2014-01-06. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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..
- Recalling firm
- Precision Dynamics Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-07-10
- Terminated
- 2014-01-06
- Firm location
- Valencia, CA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.