BEUDAMED
    FDA Enforcement Class II Terminated

    Polypropylene Surgical Sutures, brand Webglo, for vet use. Product is sterile. Part number: GP8665 Product Usage: For use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurological surgery.

    Recall: Z-2762-2016 · Reported September 14, 2016

    Enforcement

    Recall Number
    Z-2762-2016
    Event ID
    74891
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Riverpoint Medical, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    September 14, 2016
    Initiation Date
    August 5, 2016
    Classification Date
    September 8, 2016
    Termination Date
    December 22, 2016
    Address
    825 NE 25th Ave, Portland, OR, 97232-2304, United States

    Description

    Polypropylene Surgical Sutures, brand Webglo, for vet use. Product is sterile. Part number: GP8665 Product Usage: For use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurological surgery.

    Reason

    Polypropylene Surgical Sutures are recalled because the seals may become open during distribution or subsequent packaging.

    Code Info

    Lot For Vet use: 160218-05V

    Distribution

    US Nationwide distribution in the states of ID, MA, OR, NY and in the country of Australia.

    Quantity

    61 boxes distributed in the US only