BEUDAMED
    FDA Enforcement Class II Terminated

    Covidien CV-9590 Velosorb Fast Braided Fast absorbable Suture 14 Metric 36" 90 cm, GS-24 Taper 1/2 40 mm, undyed, UDI: 10884521151307

    Recall: Z-0949-2021 · Reported February 10, 2021

    Enforcement

    Recall Number
    Z-0949-2021
    Event ID
    87036
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Riverpoint Medical, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 10, 2021
    Initiation Date
    December 9, 2020
    Classification Date
    February 3, 2021
    Termination Date
    April 21, 2023
    Address
    825 NE 25th Ave, Portland, OR, 97232-2304, United States

    Description

    Covidien CV-9590 Velosorb Fast Braided Fast absorbable Suture 14 Metric 36" 90 cm, GS-24 Taper 1/2 40 mm, undyed, UDI: 10884521151307

    Reason

    Due to a manufacturing error, there is a potential that sutures may exhibit inadequate tensile strength. This could potentially lead to intra-operative and post-operative complications such as suture break or wound dehiscence.

    Code Info

    Lot # 19062715X

    Distribution

    US: NJ OUS: Germany, Croatia, Italy, India, Poland and Spain.

    Quantity

    3060 units