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U.S. Department of Health and Human Services

Class 2 Device Recall Nonsterile Viscot Part Number 1437100 Surgical Skin Markers

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  Class 2 Device Recall Nonsterile Viscot Part Number 1437100 Surgical Skin Markers see related information
Date Initiated by Firm July 10, 2013
Date Posted August 02, 2013
Recall Status1 Terminated 3 on January 06, 2014
Recall Number Z-1872-2013
Recall Event ID 65724
Product Classification skin markers - Product Code FZZ
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.
Code Information Part Number: PDC PN STE-VIS (Viscot PN 1437-100)  Lot: 061313.
Recalling Firm/
Manufacturer		 Precision Dynamics Corporation
27770 Entertainment Dr
Suite 200
Valencia CA 91355
For Additional Information Contact
818-897-1111
Manufacturer 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.
FDA Determined
Cause 2		 Component change control
Action Precision Dynamics Corp. (PDC) sent a Urgent: Skin Marker Pen Recall letter dated July 10, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. All affected customers have also been contacted by phone and email as of July 12, 2013 We want to take every precaution to ensure patient safety. 1. Immediately examine your inventory 2. Quarantine the product subject to recall 3. Complete and return the enclosed response form as soon as possible Your PDC Healthcare customer service representative will contact you directly to arrange the return of the product. In addition, if you may have distributed this product, please identify your customers and notify them at once of this product recall. Your customer notification may be enhanced by including a copy of this recall notification letter. If you have any questions please call the PDC Healthcare Returns Department at 800-435-4242 ext. 5003. Thank you for your understanding and assistance related to this matter.
Quantity in Commerce 1,200 pens
Distribution US Distribution including the states of SC, TX, TN, WA, OK.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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