BEUDAMED
    FDA Recall Terminated

    GemStar infusion pump, List numbers 13000 and 13100, GemStar Infusion Pump (pain management) List number 13150. Used for intravenous, arterial, subcutaneous, short-term epidural infusion and parenteral administration of general I.V. fluids, medications, nutritional fluids, and blood/blood products.

    Recall: Z-2031-2014 · Initiated January 31, 2014

    Recall

    Recall Number
    Z-2031-2014
    Event Number
    68200
    Firm
    Hospira Inc.
    FEI Number
    3013319212
    Product Code
    FRN
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    January 31, 2014
    Posted
    July 10, 2014
    Terminated
    August 30, 2016
    Address
    275 N Field Dr, Lake Forest, IL, 60045-2579

    Description

    GemStar infusion pump, List numbers 13000 and 13100, GemStar Infusion Pump (pain management) List number 13150. Used for intravenous, arterial, subcutaneous, short-term epidural infusion and parenteral administration of general I.V. fluids, medications, nutritional fluids, and blood/blood products.

    Reason

    The connection between the beeper subassembly and the pump may fail. The GemStar infusion pump will identify this failure during the "self-test" while powering up which will result in a Beeper Error ("code 10/001/000"). This Beeper Error (code 10/001/000) is a service alarm that places the pump in an inoperable mode and requires service before it can be returned to service.

    Action

    Hospira sent an URGENT MEDICAL DEVICE RECALL letter dated January 31, 2014 was sent to all affected customers. The letter included instructions for customers to: 1) inform potential users of these devices of the notification, 2) if the beeper error occurs during power up, remove the device from service immediately, 3) report any beeper errors to Hospira by calling 800-441-4100 (Monday - Friday, 8:00 AM - 5:00 PM CST) or e-mail [email protected], 4) complete the attached reply form and return it to the fax number of e-mail address on the form (even if there is no product in inventory), and 5) if the products were further distributed, notify those customers that received the products and ask them to contact Stericycle at 855-827-6578 (Monday - Friday, 8:00 AM - 5:00 PM EST) to receive a reply form. A subsequent letter was sent on February 18, 2014 that included a correction to the description of the error code generated when a beeper wire failure occurs. That letter included identical instructions as those found in the January 31, 2014 letter for recipients to follow.

    Distribution

    Worldwide Distribution - US: Nationwide in the state 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, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY including District Of Columbia, Guam, Puerto Rico; and the countries of Austria, Australia, Bahrain, Belgium, Canada, Chile, France, Germany, Greece, Guatemala, Hong Kong, Italy, Jordan, Kuwait, Lebanon, Libya, Luxembourg, Malaysia, Mexico, Netherlands, Oman, Portugal, Saudi Arabia, Slovenia, South Africa, Spain, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela

    Quantity

    36,881 infusion pumps