BEUDAMED
    FDA Enforcement Class II Terminated

    Plum XL, Micro Macro Plum XL3 with data port, and Micro Macro Plum XL with data port infusion pumps, indicated for intravenous, arterial, short-term epidural, and parenteral administration of general I.V. fluids, medications, nutritional fluids, and blood/blood products to patients in hospital and home care environments.

    Recall: Z-1703-2014 · Reported June 11, 2014

    Enforcement

    Recall Number
    Z-1703-2014
    Event ID
    67453
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Hospira Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 11, 2014
    Initiation Date
    January 24, 2014
    Classification Date
    June 3, 2014
    Termination Date
    November 7, 2016
    Address
    275 N Field Dr, Lake Forest, IL, 60045-2579, United States

    Description

    Plum XL, Micro Macro Plum XL3 with data port, and Micro Macro Plum XL with data port infusion pumps, indicated for intravenous, arterial, short-term epidural, and parenteral administration of general I.V. fluids, medications, nutritional fluids, and blood/blood products to patients in hospital and home care environments.

    Reason

    There is the potential for the door roller assembly on the Plum LifeCare 5000 Series and Plum XL families of infusers to break. In the event of a broken door roller pin, the door cannot appropriately lock the cassette in the right position. Depending on the conditions of a broken door roller pin, a number of events can occur. The door cannot be closed or a cassette/door alarm or a false occlusion

    Code Info

    List Number: 11555; Serial Numbers: All. List Number: 11855; Serial Numbers: All. List Number: 11859; Serial Numbers: All.

    Distribution

    Worldwide Distribution - USA nationwide including District of Columbia, Puerto Rico, and US Virgin Islands; Australia, Argentina, Bahrain, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Czech Republic, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Jordan, Kuwait, Luxembourg, Mexico, Oman, Peru, Poland, Portugal, Qatar, Russia, San Marino, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Yemen.

    Quantity

    List Number 11555: 17,887 pumps; List Number 11855: 1,292 pumps; List Number 11859: 147,399 pumps