BEUDAMED
    FDA Recall Terminated

    Plum A+3 Infusion Pump. List Number 12618. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self-contained, microprocessor based infusion devices.

    Recall: Z-2729-2016 · Initiated February 6, 2013

    Recall

    Recall Number
    Z-2729-2016
    Event Number
    64261
    Firm
    Hospira Inc.
    FEI Number
    3013319212
    Product Code
    FRN
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    February 6, 2013
    Posted
    September 6, 2016
    Terminated
    November 14, 2016
    Address
    275 N Field Dr, Lake Forest, IL, 60045-2579

    Description

    Plum A+3 Infusion Pump. List Number 12618. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self-contained, microprocessor based infusion devices.

    Reason

    The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of therapy.

    Action

    Hospira sent an Urgent Device Field Correction letter, dated February 6, 2013, to customers. Customers were requested to return a reply form to Stericycle indicating that they have received the letter, and notified their users and/or customers. The customers were asked to supply the number of Plum A+ infusers at their facility. Product will be corrected by Hospira in the field.

    Distribution

    United States nationwide distribution including PR, and USVI. Costa Rica, Turks and Caicos, and Dominican Republic.

    Quantity

    357,778 total