BEUDAMED
    FDA Enforcement Class II Terminated

    Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" P-12 Cutting, Product Number: SV426, UDI: 20884521151731 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.

    Recall: Z-0012-2021 · Reported October 7, 2020

    Enforcement

    Recall Number
    Z-0012-2021
    Event ID
    86254
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Riverpoint Medical, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    October 7, 2020
    Initiation Date
    August 3, 2020
    Classification Date
    October 1, 2020
    Termination Date
    September 8, 2022
    Address
    825 NE 25th Ave, N/A, Portland, OR, 97232-2304, United States

    Description

    Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" P-12 Cutting, Product Number: SV426, UDI: 20884521151731 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.

    Reason

    The surgical suture is non-sterile. Use could compromise the sterile field, increase risk of a surgical site infection, and increase break strength retention.

    Code Info

    Lot Number: 20051216FX

    Distribution

    US Nationwide distribution.

    Quantity

    8623