Events

Recall of Hospira LifeCare 4200 Patient-Controlled Analgesia (PCA) Infuser, PCA with MedNet Software Infusers (general purpose infusion pump).4200 PCA Infuser; List Number 610F78201PCA and PCA with MedNet Software Infusers; List Number: 612070901

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-2012-RN-00936-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2012-09-28
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00936-1
  • 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
    Hospira has received reports overseas from customers related to the improper use of the slide clamp when the syringe (vial) was manipulated or when stopping infusion during delivery of fluids. users are being informed of the correct usage of the slide clamp and/or syringe manipulation to prevent over delivery.
  • Action
    Customers are being advised of the correct use of the c slide clamp and/or syringe manipulation to prevent over delivery.

Device

Hospira LifeCare 4200 Patient-Controlled Analgesia (PCA) Infuser, PCA with MedNet Software Infuse...
  • Model / Serial
    Hospira LifeCare 4200 Patient-Controlled Analgesia (PCA) Infuser, PCA with MedNet Software Infusers (general purpose infusion pump).4200 PCA Infuser; List Number 610F78201PCA and PCA with MedNet Software Infusers; List Number: 612070901ARTG Number: 138109
  • Manufacturer
    Hospira Pty Limited

Manufacturer

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