Events

Recall of Papoose Infant Spine Immobilisers

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Ossur Australia - OA & Injury Solutions 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-2016-RN-00422-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-04-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00422-1
  • 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
    Ossur has identified that the use of undeclared natural rubber latex in the leg (perineal) strap. latex is a known allergen which can lead to allergic reactions in persons sensitive to latex. no injuries have been reported to date.
  • Action
    Ossur has replaced the affected product with unaffected stock. This action has been closed-out on 11/11/2016.

Device

Papoose Infant Spine Immobilisers
  • Model / Serial
    Papoose Infant Spine ImmobilisersPart Numbers Affected: PA-100, PAR-100 with replacement pads, PO-100 w/o P0 FRT, POR-100 w/o P0 FRT w/padLot Numbers: before MX150727ARTG Number: 135078
  • Manufacturer
    Ossur Australia - OA & Injury Solutions Pty Ltd

Manufacturer

Ossur Australia - OA & Injury Solutions Pty Ltd
  • Manufacturer Parent Company (2017)
    Össur hf
  • Source
    DHTGA