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
    131591
  • Event Risk Class
    I
  • Event Initiated Date
    2011-10-14
  • 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
    Hospira received complaints relating to incorrect seating of the regulator closer. as a result of this failure unrestricted flow may occur which could contribute to life-threatening adverse events.

Device

  • Model / Serial
    Model Catalog: 20792 (Lot serial: >100 S/N number Contact Mfg); Model Catalog: 20679 (Lot serial: >100 S/N number Contact Mfg); Model Catalog: 20678 (Lot serial: >100 S/N number Contact Mfg); Model Catalog: 12618 (Lot serial: >100 S/N number Contact Mfg); Model Catalog: 12391 (Lot serial: >100 S/N number Contact Mfg)
  • Product Description
    Plum A+ Volumetric Infusion Pump
  • Manufacturer

Manufacturer

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