BEUDAMED
    FDA Recall 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 · Initiated February 1, 2019

    Recall

    Recall Number
    Z-0979-2019
    Event Number
    82124
    Firm
    Cook Inc.
    FEI Number
    1820334
    Product Code
    DRC
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    February 1, 2019
    Posted
    March 13, 2019
    Terminated
    June 30, 2020
    Address
    750 N Daniels Way, Bloomington, IN, 47404-9120

    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.

    Action

    Urgent Medical Device Recall notification letters were sent to customers on 2/1/19. Action to take 1. Examine your inventory immediately to determine if you have affected product(s), and quarantine affected product(s). Immediately cease all distribution and use of these products. 2. Return the affected product(s) to Cook Medical with a copy of the Acknowledgement and Receipt Form to receive a product credit. NOTE: Unaffected products that are returned will not be credited. 3. Please complete the Acknowledgement and Receipt Form within 5 business days of receiving this letter. Even if you do not have affected product(s) on hand, you must still complete the Acknowledgement and Receipt Form and return it via fax (812.339.7316) or email ([email protected]). 4. This notice must be shared with appropriate personnel, including down to the user level, within your organization or with any organization where the potentially affected devices have been transferred. 5. Immediately report adverse events to Cook Medical Customer Relations by phone at 800.457.4500 or 812.339.2235, Monday through Friday between 7:30 am and 5:00 pm (Eastern Time) or by email to [email protected].

    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