BEUDAMED
    FDA Enforcement Class II Terminated

    Check-Flo Performer Introducer, Catalog Number RCFW-5.0-25-45-RB-CHB, GPN G11571

    Recall: Z-0851-2019 · Reported February 27, 2019

    Enforcement

    Recall Number
    Z-0851-2019
    Event ID
    82007
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cook Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 27, 2019
    Initiation Date
    December 21, 2018
    Classification Date
    February 20, 2019
    Termination Date
    April 30, 2020
    Address
    750 N Daniels Way, Bloomington, IN, 47404-9120, United States

    Description

    Check-Flo Performer Introducer, Catalog Number RCFW-5.0-25-45-RB-CHB, GPN G11571

    Reason

    The products were manufactured with longer than specified sheaths.

    Code Info

    lot 8858425

    Distribution

    The products were distributed to the following US states: CA, CT, GA, MA, NY, PA, VA, and WI.

    Quantity

    24