Events

Recall of Plum A+ Infusion Pump and Software Module

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Hospira Pty Limited.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2013-RN-01268-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2013-11-29
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01268-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
    ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
  • Extra notes in the data
  • Reason
    The plum a+ software module includes a switch port label stating: "for use with list 12391-36 only". this label should state: "for use with list 12391-36 and list 11971-36 only".
  • Action
    Hospira is replacing the Switch Port Label with the corrected version.

Device

Plum A+ Infusion Pump and Software Module
  • Model / Serial
    Plum A+ Infusion Pump and Software ModulePlum A+ Infusion PumpCatalogue Number: 611179101Number on device: 11971-36Plum A+ Software Module:Catalogue Numbers: 611209701Number on device: 12097-36-01 and 12097-36-02ARTG Number: 138109
  • Manufacturer
    Hospira Pty Limited

Manufacturer

Hospira Pty Limited
  • Manufacturer Parent Company (2017)
    Pfizer
  • Source
    DHTGA