BEUDAMED
    FDA Recall Terminated

    GemStar Bolus Cord; a remote bolus cord and switch for use with GemStar 7 Therapy and Pain Management Pumps, list 13000, 13150, 13087 and 13088; Hospira, Inc., Lake Forest, IL 60045; List Number 13027; An accessory for the infusion pump that allows bolus requests to be made by a patient or clinician up to 6 feet (1.8 m) away from the pump.

    Recall: Z-1463-2012 · Initiated March 28, 2012

    Recall

    Recall Number
    Z-1463-2012
    Event Number
    61472
    Firm
    Hospira Inc.
    FEI Number
    3013319212
    Product Code
    FRN
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    March 28, 2012
    Posted
    April 26, 2012
    Terminated
    September 14, 2016
    Address
    275 N Field Dr, Lake Forest, IL, 60045-2579

    Description

    GemStar Bolus Cord; a remote bolus cord and switch for use with GemStar 7 Therapy and Pain Management Pumps, list 13000, 13150, 13087 and 13088; Hospira, Inc., Lake Forest, IL 60045; List Number 13027; An accessory for the infusion pump that allows bolus requests to be made by a patient or clinician up to 6 feet (1.8 m) away from the pump.

    Reason

    Hospira has received customer reports of bolus delivery failures when using the GemStar bolus cord. Possible failures may be a result of cracked or damaged bolus cords which may result in an open or short circuit of the Bolus Cord.

    Action

    Hospira, sent an "URGENT DEVICE FIELD CORRECTION RECALL" letter dated March 28, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The customers were instructed to take care when removing the bolus cord from the base of the GemStar unit, inspect the cord for damage, discontinue using any damaged cords, and to call Hospira at 1-800-241-4002 for replacement. A Reply Form was enclosed for customers to complete and return via fax to 1-866-912-7085 or e-mail to: [email protected]. Contact Hospira Customer Care at 1-877-946-7747 for technical assistance.

    Distribution

    Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Denmark, Egypt, Finland, France, Germany, Gibraltar, Greece, Guatemala, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Lebanon, Libya, Luxembourg, Malaysia, Malta, Mexico, Netherlands, New Zealand, Nola, Norway, Oman, Philippines, Portugal, Qatar, Romania, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay and Venezuela.

    Quantity

    47,127 cords - U.S. and 39,968 cords - ROW