BEUDAMED
    FDA Enforcement Class I Terminated

    Cook Transseptal Needle, Reference Number TSNC-18-71.0, Order Number G02364. For transseptal left heart access in both diagnostic and interventional procedures.

    Recall: Z-0979-2019 · Reported March 20, 2019

    Enforcement

    Recall Number
    Z-0979-2019
    Event ID
    82124
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cook Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 20, 2019
    Initiation Date
    February 1, 2019
    Classification Date
    March 13, 2019
    Termination Date
    June 30, 2020
    Address
    750 N Daniels Way, N/A, Bloomington, IN, 47404-9120, United States

    Description

    Cook Transseptal Needle, Reference Number TSNC-18-71.0, Order Number G02364. For transseptal left heart access in both diagnostic and interventional procedures.

    Reason

    The products were manufactured without a back bevel on the needle tip. This could cause damage to the inside of the introducer during needle insertion.

    Code Info

    Lot 8833687

    Distribution

    US nationwide and Canada. US distribution to the following states: AZ, FL, IL, IN, KS, MA, MI, MO, PA, SC, TN, and WA. The products were distributed to the following foreign countries: Canada.

    Quantity

    100