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.
FDA Recall Z-1872-2013 · Posted 2013-08-02
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Recalling FirmPrecision Dynamics Corporation
Recall StatusTerminated
Product CodeFZZ
Date Initiated2013-07-10
Date Terminated2014-01-06
Product Quantity1,200 pens
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.
Firm 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.
Root Cause
Component change control
Distribution Pattern
US Distribution including the states of SC, TX, TN, WA, OK.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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