BEUDAMED
    FDA Enforcement Class I Terminated

    The GemStar Power Supply is an accessory for the GemStar Infusion Pump. It is a two piece assembled switching power supply. The Power Supply converts alternating current (AC) line input voltage of 120 or 240 V to an output to the device of 3.3 Volts DC.

    Recall: Z-0095-2015 · Reported November 5, 2014

    Enforcement

    Recall Number
    Z-0095-2015
    Event ID
    68047
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Hospira Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 5, 2014
    Initiation Date
    February 3, 2014
    Classification Date
    October 24, 2014
    Termination Date
    March 7, 2017
    Address
    275 N Field Dr, N/A, Lake Forest, IL, 60045-2579, United States

    Description

    The GemStar Power Supply is an accessory for the GemStar Infusion Pump. It is a two piece assembled switching power supply. The Power Supply converts alternating current (AC) line input voltage of 120 or 240 V to an output to the device of 3.3 Volts DC.

    Reason

    The GemStar Infusion pump may not receive direct current (DC) power from the power supply. In one instance, smoke was observed and the GemStar pump was operating on battery power while connected to the 3 volt DC power supply.

    Code Info

    Wall Mount GemStar Power Supply List Number: 13026; Lot Numbers: 25283G1, 26286G1, 26287G1, 27292G1, 27294G1, 27295G1, 27296G1

    Distribution

    Worldwide Distribution -- USA, including the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY; and, the countries of Austria, Belgium, Brazil, Columbia, France, Germany, Greece, Netherlands, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Turkey, and United Kingdom.

    Quantity

    978 power supplies