Device Recall Nonsterile Viscot Part Number 1437100 Surgical Skin Markers 의 리콜

Recall

65724

Class 2

Z-1872-2013

2013-07-10

2013-08-02

Terminated

United States

2014-01-06

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119963

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.

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.