BEUDAMED
    FDA Recall Open, Classified

    Check=Flo Performer Introducer, 14.0Fr, Reference Part Number(RPN) REF RCFW-14.0-0-38-30-RB, Order Number (GPN) REF G08957,

    Recall: Z-1787-2025 · Initiated April 17, 2025

    Recall

    Recall Number
    Z-1787-2025
    Event Number
    96703
    Firm
    Cook Incorporated
    FEI Number
    1820334
    Product Code
    DYB
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    April 17, 2025
    Posted
    May 16, 2025
    Address
    750 N Daniels Way, Bloomington, IN, 47404-9120

    Description

    Check=Flo Performer Introducer, 14.0Fr, Reference Part Number(RPN) REF RCFW-14.0-0-38-30-RB, Order Number (GPN) REF G08957,

    Reason

    Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath.

    Action

    Cook Medical issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 04/17/2025 via FedEx Standard Overnight. The notice explained the issue, potential risk to health and requested: Actions to be Taken by the Customer 1. Examine inventory immediately to determine if you have affected product(s) and quarantine any affected product that remains unused. Immediately cease all further distribution and use of the affected products. 2. Return the affected product(s) to Cook Medical with a copy of the Acknowledgement and Receipt Form to receive a product credit. Refer to the Acknowledgement and Receipt Form for return instructions. 3. Please complete the Acknowledgement and Receipt Form within 5 business days of receiving this letter regardless of whether you have affected product(s) on hand. You may return the Form 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 affected devices have been transferred. 5. Please immediately report adverse events to Cook Medical Customer Relations by phone at 800.457.4500 or 812.339.2235, Monday through Friday between 7:30am and 5:00pm (Eastern Time), or by email to: [email protected].

    Distribution

    Worldwide distribution - US Nationwide and the countries of Belgium, Germany, Spain, France, Ireland, Italy Netherlands, Switzerland, South Africa, Slovenia.

    Quantity

    89 units