BEUDAMED
    FDA Recall 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 · Initiated October 7, 2019

    Recall

    Recall Number
    Z-2070-2020
    Event Number
    85353
    Firm
    Baylis Medical Company Inc.
    FEI Number
    3000157372
    Product Code
    DYB
    Status
    Terminated
    Root Cause
    Package design/selection
    Initiated
    October 7, 2019
    Posted
    May 21, 2020
    Terminated
    June 30, 2021
    Address
    2645 Matheson Blvd E, Mississauga 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.

    Action

    The firm sent Urgent Medical Device Recall Notification letters to customers via UPS and/or by email on 07-Oct-2019. The notifications were followed through by a tracking number to facilitate confirmation of package delivery. Customers were informed that all Torflex Transseptal Guiding Sheaths sold separately or as part of the NRG Transseptal kit are affected by this action. Customers were instructed to examine their stock, determine whether they had any of the affected lot numbers in stock, and if so, to quarantine affected product. Customers were requested to complete the acknowledgement form and return it to Baylis within 3 business days by email at [email protected] or by faxing the completed form to 906-602-5671 Attn: Quality Department. Customers were informed that once the completed Acknowledgement form was received by Baylis, they would be contacted by a Baylis Medical Representative within 5 business days to manage the disposition of any identified quarantined product. Customers were instructed to address specific questions regarding the recall to Mrs. Ellen Harfield, Director of Quality at 1-800-276-4416.

    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).