BEUDAMED
    FDA Enforcement Class II Terminated

    NRG RF Transseptal Kit; Model No.s : NTK-710-8545, NTK-710-8555, NTK-711-8545, NTK-711-8555, NTK-711-8590, NTK-P711-8545, NTK-P711-8555, NTK-710-8545S, NTK-710-8555S, NTK-711-8545S, NTK-711-8555S, NTK-710-8545N, NTK-711-8545N and NTK-711-8555N.

    Recall: Z-2070-2020 · Reported May 27, 2020

    Enforcement

    Recall Number
    Z-2070-2020
    Event ID
    85353
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Baylis Medical Company Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    May 27, 2020
    Initiation Date
    October 7, 2019
    Classification Date
    May 21, 2020
    Termination Date
    June 30, 2021
    Address
    2645 Matheson Blvd E, N/A, Mississauga, N/A, N/A, Canada

    Description

    NRG RF Transseptal Kit; Model No.s : NTK-710-8545, NTK-710-8555, NTK-711-8545, NTK-711-8555, NTK-711-8590, NTK-P711-8545, NTK-P711-8555, NTK-710-8545S, NTK-710-8555S, NTK-711-8545S, NTK-711-8555S, NTK-710-8545N, NTK-711-8545N and NTK-711-8555N.

    Reason

    There is a remote potential for the sterile packaging of the transseptal guiding sheath to be compromised during shipping and handling. In the case that a packaging defect is not identified and the product is used in a patient, there may be a remote risk of infection.

    Code Info

    All lot numbers of the following kit model numbers: NTK-710-8545, NTK-710-8555, NTK-711-8545, NTK-711-8555, NTK-711-8590, NTK-P711-8545, NTK-P711-8555, NTK-710-8545S, NTK-710-8555S, NTK-711-8545S, NTK-711-8555S, NTK-710-8545N, NTK-711-8545N, and NTK-711-8555N.

    Distribution

    Product distributed throughout the 50 states and in Washington D.C.

    Quantity

    Total of 59067 units (includes both individual units and those sold in NRG RF Transseptal Kits).