BEUDAMED
    FDA Enforcement Class II Terminated

    Elite HV Introducer, Catalog #: a) CLI-200-26; b) CLI-210-16; c) CLI-212-07; d) KCL-212-055

    Recall: Z-2562-2018 · Reported August 8, 2018

    Enforcement

    Recall Number
    Z-2562-2018
    Event ID
    80021
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Galt Medical Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 8, 2018
    Initiation Date
    May 2, 2018
    Classification Date
    July 27, 2018
    Termination Date
    July 20, 2020
    Address
    2220 Merritt Dr, N/A, Garland, TX, 75041-6137, United States

    Description

    Elite HV Introducer, Catalog #: a) CLI-200-26; b) CLI-210-16; c) CLI-212-07; d) KCL-212-055

    Reason

    The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also called pyrogenic bacteria can activate the inflammatory process and produce fever, chills, and hypotension in a patient.

    Code Info

    Lot #: a) 18032057, 18032058; b) 18001013, 18046016, 18162838; c) 18019455 18019456, 18019457, 18019458, 18019460, 18047461, 18047462, 18047463; d) 17363374, 18116090

    Distribution

    U.S.: MN, PA, VA, CA, UT, FL, NY, GA, LA, MO, TX, MS, OH, WA, MA, IL, KY, NC, and Puerto Rico; OUS: Canada, Australia, France, Germany, Ireland, Italy, Netherlands, Poland, Slovakia, Switzerland, Belgium, United Kingdom, Korea

    Quantity

    10950