BEUDAMED
    FDA Recall Terminated

    Plum A+3 Triple Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps were sold under the following configurations: a) list 12348 - software version 10.3; b) list 12618 - software version 11.3; c) list 20678 - Hospira MedNet software The Plum A+3 is a dual-line triple channel volumetric infusion system designed to meet the growing demand for hospital-wide, as well as alternate site and home healthcare, standardization. With their primary line, secondary line, and piggyback fluid delivery capability, the Plum A+3 is suited for a wide range of medical/surgical and critical care applications. Full compatibility with LifeCare Plum Series administration sets and accessories and the LifeShield needleless protection systems makes the Plum A+3 a convenient and cost-effective infusion system.

    Recall: Z-3285-2011 · Initiated September 16, 2011

    Recall

    Recall Number
    Z-3285-2011
    Event Number
    59953
    Firm
    Hospira Inc.
    FEI Number
    3013319212
    Product Code
    FRN
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    September 16, 2011
    Posted
    September 29, 2011
    Terminated
    November 7, 2016
    Address
    275 N Field Dr, Lake Forest, IL, 60045-2579

    Description

    Plum A+3 Triple Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps were sold under the following configurations: a) list 12348 - software version 10.3; b) list 12618 - software version 11.3; c) list 20678 - Hospira MedNet software The Plum A+3 is a dual-line triple channel volumetric infusion system designed to meet the growing demand for hospital-wide, as well as alternate site and home healthcare, standardization. With their primary line, secondary line, and piggyback fluid delivery capability, the Plum A+3 is suited for a wide range of medical/surgical and critical care applications. Full compatibility with LifeCare Plum Series administration sets and accessories and the LifeShield needleless protection systems makes the Plum A+3 a convenient and cost-effective infusion system.

    Reason

    Hospira has received reports of incorrect seating of the regulator closer on the Plum A+ Infusion Pumps. If the regulator closer does not close the flow regulator actuator when the pump door is opened, and if the clinician has not engaged the clamp prior to opening the cassette door, unrestricted flow may occur.

    Action

    Hospira, Inc. sent an "URGENT DEVICE RECALL" letter dated September 16, 2011 to all affected customers. The letter describes the product, problem and actions to be taken by the customers. The letter instructs customers on how to prevent occurrences of continuous recycling/rebooting during start-up. A reply form was attached to the letter for customers to complete and return via fax to 1-888-345-5358. Contact Hospira Advanced Knowledge Center at 1-800-241-4002, option 4, for technical assistance or information regarding this notice.

    Distribution

    Worldwide Distribution-USA (nationwide) including Puerto Rico and the U. S. Virgin Islands and countries of Argentina, Australia, Bahamas, Barbados, Belgium, Brazil, Canada, Chile, Colombia, Costa Rica, Denmark, Dominican Republic, Ecuador, France, Greece, Hong Kong, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Lebanon, Libya, Malaysia, Mexico, Netherlands, New Zealand, Oman, Pakistan, Peru, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United kingdom, United Arab Emirates, Uruguay and Vietnam.

    Quantity

    24,992 pumps