BEUDAMED
    FDA Enforcement Class II Terminated

    Bipolar Forceps model number: S02-XXX, S03-XXX, P02-XXX, and P03-XXX. "Instructions For Use" (QF7.5.1A.R01 thru QF7.5.1A.R06 Care and Handling of Bipolar Forceps. Bipolar Forceps designed to grasp, manipulate and coagulate selected tissue for use in general surgical procedures powered by a high frequency generator.

    Recall: Z-2011-2012 · Reported July 25, 2012

    Enforcement

    Recall Number
    Z-2011-2012
    Event ID
    62024
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stingray Surgical Products, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    July 25, 2012
    Initiation Date
    May 23, 2012
    Classification Date
    July 13, 2012
    Termination Date
    August 6, 2014
    Address
    156 Nw 16th St, Boca Raton, FL, 33432-1607, United States

    Description

    Bipolar Forceps model number: S02-XXX, S03-XXX, P02-XXX, and P03-XXX. "Instructions For Use" (QF7.5.1A.R01 thru QF7.5.1A.R06 Care and Handling of Bipolar Forceps. Bipolar Forceps designed to grasp, manipulate and coagulate selected tissue for use in general surgical procedures powered by a high frequency generator.

    Reason

    On 05/23/2012, Stingray Surgical Products, LLC., Boca Raton, FL initiated a recall initiated due to "Instructions For Use" of Bipolar Forceps not being cleared by FDA and incorrect "Instructions For Use" . The sterilization instructions have been altered without the clearance of the FDA.

    Code Info

    Bipolar Forceps model number: S02-XXX, S03-XXX, P02-XXX, and P03-XXX. "Instructions For Use" (QF7.5.1A.R01 thru QF7.5.1A.R06 Care and Handling of Bipolar Forceps.

    Distribution

    Worldwide Distribution - USA (nationwide)

    Quantity

    6326