BEUDAMED
    FDA Recall Terminated

    Vycor Medical ViewSite Brain Access System 17mm/ 11mm / 5cm Device***STERILE*** Product Usage: The Vycor Viewsite Brain Access System (VBAS) has been designed to serve as a self-retaining retractor system for brain tissue. It is comprised of an introducer and a working channel port that are secured by a spring-loaded latch. Each device allows for the gentle retraction of tissue, visualization of the surgical site and for the smooth manipulation of introduced instruments. The range of device sizes (width and length) provides various working channel sizes.

    Recall: Z-0673-2013 · Initiated August 21, 2012

    Recall

    Recall Number
    Z-0673-2013
    Event Number
    63319
    Firm
    Vycor Medical, Inc.
    FEI Number
    3005880844
    Product Code
    GZT
    Status
    Terminated
    Root Cause
    Equipment maintenance
    Initiated
    August 21, 2012
    Posted
    January 17, 2013
    Terminated
    May 13, 2013
    Address
    6401 Congress Ave, Ste 140, Boca Raton, FL, 33487-2841

    Description

    Vycor Medical ViewSite Brain Access System 17mm/ 11mm / 5cm Device***STERILE*** Product Usage: The Vycor Viewsite Brain Access System (VBAS) has been designed to serve as a self-retaining retractor system for brain tissue. It is comprised of an introducer and a working channel port that are secured by a spring-loaded latch. Each device allows for the gentle retraction of tissue, visualization of the surgical site and for the smooth manipulation of introduced instruments. The range of device sizes (width and length) provides various working channel sizes.

    Reason

    Vycor Medical recalled their VBAS (Vycor Viewsite Brain Access System) because an unidentified black fiber was found on the device.

    Action

    Vycor Medical, Inc. notified all customers of the product recall by telephone and follow-up letter. Customers were instructed to quarantine affected products and hold the shipment(s) in quarantine unti further notice. The units will be replaced with inspected and passed units. All distributors were instructed to notify their customers of the recall and ask to have them return their stock. For question call 561-558-2020.

    Distribution

    Worldwide Distribution - USA (Nationwide) in the states of TX, IL, NJ, FL, OH, PA and (International) in the country of Japan.

    Quantity

    3000 devices