Events

Recall of PCA Empty Sterile vials with injector. (Intravenous fluid container).

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-00800-3
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-08-10
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00800-3
  • 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
    There have been reports of leaking injectors on the empty sterile vial. hospira's investigation concluded that injectors had a manufacturing defect in the promixal 'adhesive well' area due to a weak adhesive bond. the injectors accompanying the empty sterile vials may have an increased risk of leaking, particularly during the filling process.
  • Action
    The sponsor is providing work around instructions to mitigate the risk.

Device

PCA Empty Sterile vials with injector. (Intravenous fluid container).
  • Model / Serial
    PCA Empty Sterile vials with injector. (Intravenous fluid container).List Number: 060210403ARTG number: 166111
  • Manufacturer
    Hospira Pty Limited

Manufacturer

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