Recall of PLUM A+ VOLUMETRIC INFUSION PUMP

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
    18633
  • Event Risk Class
    II
  • Event Initiated Date
    2013-02-21
  • Event Country
  • 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
    Possible interruption of therapy may occur when an e321 error code occurs while using a plum a+/a+3 infuser. the e321 error code occurs when the plum a+/a+3 infuser is operating on ac power and the software detects that the battery could not be fully recharged within 8 hours.

Device

  • Model / Serial
    Model Catalog: 20679 (Lot serial: All Serial Numbers); Model Catalog: 20792 (Lot serial: All Serial Numbers); Model Catalog: 12618 (Lot serial: All Serial Numbers); Model Catalog: 11005 (Lot serial: All Serial Numbers); Model Catalog: 20678 (Lot serial: All Serial Numbers); Model Catalog: 12391 (Lot serial: All Serial Numbers)
  • Product Description
    All Plum A+/A+3 Family of Infusers
  • Manufacturer

Manufacturer

  • Manufacturer Address
    SAINT-LAURENT
  • Manufacturer Parent Company (2017)
  • Source
    HC