Events

Recall of Vapotherm Disposable Patient Circuit System (Delivers high flow humidified gases via a nasal cannula or other patient interface)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Surgical Specialties 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-2014-RN-00916-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-08-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00916-1
  • 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
    Vapotherm inc. has received a small number of complaints involving a defect in the disposable patient circuit delivery tube. the defect allows water to leak into the centre lumen of the delivery tube, the gas line to the patient. the fault condition is easily detectable and typically occurs while the device is coming up to the set temperature and is easily visible when following the precision flow instructions for use, which requires that the cannula be connected to the patient only after the set temperature is reached.
  • Action
    Customers are asked to check their stock immediately to determine if they have any affected product. Customers are advised to return the affected stock to Surgical Specialties Pty Ltd. This action has been closed-out on 10/05/2017.

Device

Vapotherm Disposable Patient Circuit System (Delivers high flow humidified gases via a nasal cann...
  • Model / Serial
    Vapotherm Disposable Patient Circuit System (Delivers high flow humidified gases via a nasal cannula or other patient interface)Part Numbers: PF-DPC-High, PF-DPC-Low Lot Numbers: HF1402035, HF1404043, LF1402030, LF1405023ARTG Number: 147794
  • Manufacturer
    Surgical Specialties Pty Ltd

Manufacturer

Surgical Specialties Pty Ltd