BEUDAMED
    FDA Recall Terminated

    Plum A+ Hyperbaric Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; list 11005. 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.

    Recall: Z-3286-2011 · Initiated September 16, 2011

    Recall

    Recall Number
    Z-3286-2011
    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+ Hyperbaric Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; list 11005. 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.

    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

    120 pumps