BEUDAMED
    FDA Enforcement Class II Terminated

    SafeStep¿ Huber Needle Set with Y-Injection Site. Product Code: LH-0029YN. Packaged as single units in thermoformed trays. There are 25 SafeStep¿ trays per case and 100 per carton. Product Usage: Intended for the administration of fluids and drugs, or blood sampling through surgically implanted vascular ports.

    Recall: Z-0986-2017 · Reported January 18, 2017

    Enforcement

    Recall Number
    Z-0986-2017
    Event ID
    76008
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Bard Access Systems
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 18, 2017
    Initiation Date
    December 19, 2016
    Classification Date
    January 9, 2017
    Termination Date
    April 17, 2017
    Address
    605 N 5600 W, Salt Lake City, UT, 84116-3738, United States

    Description

    SafeStep¿ Huber Needle Set with Y-Injection Site. Product Code: LH-0029YN. Packaged as single units in thermoformed trays. There are 25 SafeStep¿ trays per case and 100 per carton. Product Usage: Intended for the administration of fluids and drugs, or blood sampling through surgically implanted vascular ports.

    Reason

    Bard Access Systems announces a voluntary field action for the SafeStep¿ Huber Needle Set with Y-Injection Site and MiniLoc¿ Safety Infusion Set Winged without Y-Injection Site devices because sets may contain one or more units where the needle length and gage differs from the length and gage described on the label.

    Code Info

    Lot Number: ASZKS076

    Distribution

    Worldwide Distribution - US Nationwide in the states of CA, CO, FL, GA, HI, IL, MA, MD, NJ, OH, OR, TX.

    Quantity

    8000 units