BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0851-2019 · Initiated December 21, 2018

    Recall

    Recall Number
    Z-0851-2019
    Event Number
    82007
    Firm
    Cook Inc.
    FEI Number
    1820334
    Product Code
    DYB
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    December 21, 2018
    Terminated
    April 30, 2020
    Address
    750 N Daniels Way, Bloomington, IN, 47404-9120

    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.

    Action

    Urgent Medical Device Recall letters dated 12/21/18 were sent to customers.

    Distribution

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

    Quantity

    24