BEUDAMED
    FDA Enforcement Class II Ongoing

    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 · Reported May 28, 2025

    Enforcement

    Recall Number
    Z-1787-2025
    Event ID
    96703
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Cook Incorporated
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 28, 2025
    Initiation Date
    April 17, 2025
    Classification Date
    May 16, 2025
    Address
    750 N Daniels Way, N/A, Bloomington, IN, 47404-9120, United States

    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.

    Code Info

    UDI/DI 00827002089570, Lot Number 16376242

    Distribution

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

    Quantity

    89 units