BEUDAMED
    FDA Enforcement Class II Terminated

    Nylon Surgical Suture for human use and vet use, sold under brand name Riverlon, Securolon, Weblon. Product is sterile. Part numbers: 663BK 663BL 664BL 928BK Product Usage: For use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurological surgery.

    Recall: Z-2761-2016 · Reported September 14, 2016

    Enforcement

    Recall Number
    Z-2761-2016
    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

    Nylon Surgical Suture for human use and vet use, sold under brand name Riverlon, Securolon, Weblon. Product is sterile. Part numbers: 663BK 663BL 664BL 928BK Product Usage: For use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurological surgery.

    Reason

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

    Code Info

    Lot For human use: 160210-02. Lots For Vet use: 160223-03V 160302-06V 160202-01V 160217-02V 160224-03V 160218-03V 160204-01

    Distribution

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

    Quantity

    2110 boxes distributed in the US and 72 boxes distributed outside US