BEUDAMED
    FDA Enforcement Class II Terminated

    Polyglycolic-Lactic Acid Absorbable Surgical Suture Label reads in part "Coated VILET *** (Polyglacin 910) Suture UNDYED BRANDED V423 *** Riverpoint ***" PGLA surgical suture is indicated for use in general soft tissue approximation and/or ligation, including use in opthalmic procedures, but not for use in cardiovascular and neurological tissues

    Recall: Z-0347-2014 · Reported November 27, 2013

    Enforcement

    Recall Number
    Z-0347-2014
    Event ID
    65584
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Riverpoint Medical, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 27, 2013
    Initiation Date
    December 13, 2012
    Classification Date
    November 18, 2013
    Termination Date
    November 21, 2013
    Address
    825 NE 25th Ave, Portland, OR, 97232-2304, United States

    Description

    Polyglycolic-Lactic Acid Absorbable Surgical Suture Label reads in part "Coated VILET *** (Polyglacin 910) Suture UNDYED BRANDED V423 *** Riverpoint ***" PGLA surgical suture is indicated for use in general soft tissue approximation and/or ligation, including use in opthalmic procedures, but not for use in cardiovascular and neurological tissues

    Reason

    Riverpoint Medical is recalling PGLA Surgical Suture (Vilet) because the label indicates the suture is undyed and it is actually a violet colored suture.

    Code Info

    Lot 120716-01

    Distribution

    US Distribution in the states of: AZ, FL, and TX.

    Quantity

    1932 pieces