The Food and Drugs Administration (FDA), United States posted a medical device safety alert concerning ViewSite Brain Access System (VBAS) 17mm/ 11mm / 5cm Device [Model no: TC171105; Lot no.: VM83450], manufactured by Vycor Medical, Inc.
According to the report, the manufacturer recalled their VBAS because an unidentified black fiber was found on the device.
For details, please visit the following FDA website:
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0673-2013&w=01232013&lang=eng
If you are in possession of the product, please contact your supplier for necessary actions.
Posted on 25 January 2013