Events

Recall of PLUM XL MICRO/MACRO INFUSION WITH DATA PORT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by HOSPIRA HEALTHCARE CORPORATION.

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
    115522
  • Event Risk Class
    I
  • Event Initiated Date
    2014-01-29
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
    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 door roller assembly on the plum lifecare 5000 series and plum xl infuser families has the potential to break which can lead to possible unrestricted flow and/or overdelivery when the door of the pump is opened.

Device

PLUM XL MICRO/MACRO INFUSION WITH DATA PORT
  • Model / Serial
    Model Catalog: 11859 (Lot serial: All Serial Numbers); Model Catalog: 11846 (Lot serial: All Serial Numbers); Model Catalog: 11781 (Lot serial: All Serial Numbers); Model Catalog: 11555 (Lot serial: All Serial Numbers); Model Catalog: 11845 (Lot serial: All Serial Numbers); Model Catalog: 2507 (Lot serial: All Serial Numbers)
  • Product Classification
    General Hospital and Personal Use Devices
  • Product Description
    Plum XLM with Data Port
  • Manufacturer
    HOSPIRA HEALTHCARE CORPORATION

Manufacturer

HOSPIRA HEALTHCARE CORPORATION
  • Manufacturer Address
    SAINT-LAURENT
  • Manufacturer Parent Company (2017)
    Pfizer
  • Source
    HC