BEUDAMED
    FDA Enforcement Class II Terminated

    B. Braun Introcan Safety IV Catheter PUR 24G, 0.7X19mm-US, catalog number 4251601-02. Product Usage: The B. Braun Introcan Safety IV Catheter is a passive anti-stick device to provide venous or arterial access for the infusion of fluids, drugs, and/or blood components, or to facilitate the placement of vascular access devices such as guidewires, indwelling central venous catheters, peripherally inserted central catheters, and midline catheters into vascular system.

    Recall: Z-0559-2014 · Reported January 1, 2014

    Enforcement

    Recall Number
    Z-0559-2014
    Event ID
    66535
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    B. Braun Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 1, 2014
    Initiation Date
    September 27, 2013
    Classification Date
    December 20, 2013
    Termination Date
    October 8, 2014
    Address
    901 Marcon Boulevard, N/A, Allentown, PA, 18109-9512, United States

    Description

    B. Braun Introcan Safety IV Catheter PUR 24G, 0.7X19mm-US, catalog number 4251601-02. Product Usage: The B. Braun Introcan Safety IV Catheter is a passive anti-stick device to provide venous or arterial access for the infusion of fluids, drugs, and/or blood components, or to facilitate the placement of vascular access devices such as guidewires, indwelling central venous catheters, peripherally inserted central catheters, and midline catheters into vascular system.

    Reason

    One lot of Introcan Safety IV Catheters may not contain the anti-needlestick safety clip which is used for the prevention of needlestick injuries.

    Code Info

    lot no. 3C30258317

    Distribution

    USA Nationwide Distribution including Puerto Rico.

    Quantity

    55,200 units