BEUDAMED
    FDA Enforcement Class II Ongoing

    Turbett Surgical Container, TS1200: Indicated for enclosing other medical devices that are to be sterilized by a healthcare provider

    Recall: Z-1037-2023 · Reported February 8, 2023

    Enforcement

    Recall Number
    Z-1037-2023
    Event ID
    91314
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Turbett Surgical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    February 8, 2023
    Initiation Date
    December 5, 2022
    Classification Date
    January 30, 2023
    Address
    668b Phillips Rd Ofc 1, N/A, Victor, NY, 14564-9741, United States

    Description

    Turbett Surgical Container, TS1200: Indicated for enclosing other medical devices that are to be sterilized by a healthcare provider

    Reason

    Pod may have weld failures breaching the sterile barrier and result in the use of unsterile instruments leading to infection or other major injuries.

    Code Info

    GTIN: 00859464007281 Lot Number: All Lot Numbers Serial Number: All Serial Numbers

    Distribution

    US Nationwide distribution in the states of CA, IA, IN, NC, NH, NY, OH, LA, SD, TX, VA, WI.

    Quantity

    61 units