Events

Recall of Salter Labs Oxygen Cannulas

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Wymedical 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-2017-RN-01545-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-01-05
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01545-1
  • 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
    Wymedical has been made aware of an issue with certain salter labs oxygen cannulas. the material used for the canulas are prone to twisting and may inhibit oxygen passage.
  • Action
    Customers are to complete the supplied acknowledgement form immediately even if they do not have any affected stock and return it to Wymedical. Return affected stock on hand as directed with the completed inventory form to receive RGA number and advise when stock is ready for pick up.

Device

Salter Labs Oxygen Cannulas
  • Model / Serial
    Salter Labs Oxygen CannulasCatalogue Number: 1615-7 and 1601-7Lot Number: SFT 072417 and Lot Number SFT073117ARTG Number; 168942 (Wymedical Pty Ltd - Cannula, nasal, oxygen)
  • Manufacturer
    Wymedical Pty Ltd

Manufacturer

Wymedical Pty Ltd