BEUDAMED
    FDA Enforcement Class II Terminated

    Turbett Surgical Container, TS1500

    Recall: Z-1501-2022 · Reported August 10, 2022

    Enforcement

    Recall Number
    Z-1501-2022
    Event ID
    90578
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Turbett Surgical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 10, 2022
    Initiation Date
    April 14, 2022
    Classification Date
    August 4, 2022
    Termination Date
    February 20, 2025
    Address
    668b Phillips Rd Ofc 1, N/A, Victor, NY, 14564-9741, United States

    Description

    Turbett Surgical Container, TS1500

    Reason

    Devices were subject to unapproved rework processes.

    Code Info

    UDI-DI (GTIN): 00859464007113; Lot No./Serial No.: 100036/2017061015, 100036/2017061016, 100036/2017061017, 100036/2017061019, 100036/2017061023, 100036/2017061025, 100065/2017121001 and 100081/2018031004.

    Distribution

    US Nationwide Nationwide: CO, FL, NC and PA.

    Quantity

    7 units