BEUDAMED
    FDA Enforcement Class II Terminated

    Henora REF: 70-4026-09V1 300psi I.V. Catheter Extension Set Product Usage: Catheter extension set for high pressure procedures.

    Recall: Z-1996-2014 · Reported July 16, 2014

    Enforcement

    Recall Number
    Z-1996-2014
    Event ID
    68552
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    RGI Medical Manufacturing, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 16, 2014
    Initiation Date
    March 28, 2014
    Classification Date
    July 6, 2014
    Termination Date
    September 29, 2016
    Address
    4637 NW 6th St, Gainesville, FL, 32609-0701, United States

    Description

    Henora REF: 70-4026-09V1 300psi I.V. Catheter Extension Set Product Usage: Catheter extension set for high pressure procedures.

    Reason

    Problem with low adhesion of the tubing to luer connection which may lead to a separation of the extension set while in use.

    Code Info

    Lot numbers 102131 and 110531.

    Distribution

    US Nationwide Distribution in the states of AL, CA, DE, GA, IL, KY, MA, MD, ME, MI, MN, NJ, NM, NV, NY, OH, TN, TX, WA, and WI.

    Quantity

    19,200 units.