Events

Recall of Two and three stage I.V. Poles (used as an optional accessory to a stretcher)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Stryker Australia Pty Ltd.

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-2015-RN-01123-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-11-17
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01123-1
  • 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.
  • Extra notes in the data
  • Reason
    It has been reported that some i.V. poles were retracting / lowering from an extended position to a low height unexpectedly. the i.V. latch housing has been identified as non-conforming, which has resulted in the suspended i.V. pole retracting.
  • Action
    Stryker is advising users to identify any of the stretcher models listed on which there may be an affected I.V. pole and place the pole at the lowest position. Stryker are supplying a sticker to be placed on the I.V. pole until the affected poles can be repaired. This action has been closed-out on 05/09/2016.

Device

Two and three stage I.V. Poles (used as an optional accessory to a stretcher)
  • Model / Serial
    Two and three stage I.V. Poles (used as an optional accessory to a stretcher)30” I.V. Pole, 2 Stage HE, PRCatalogue Number: 1105035368 Serial Number: 1403030970 26” I.V. Pole, 2 Stage HL Catalogue Number: 1105035638 Serial Number: 1402030027 Used on the following devices:Stretcher models: 1105, 1105E, 1105X, 1105XE, 1115, 1115E, 1115X, 115XE, 1125E, 1125X and 1125XEARTG Number: 167691
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    DHTGA