Events

Recall of Omrix Pressure Regulator (Surgical air pipeline regulator)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Johnson & Johnson Medical 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-00937-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-08-26
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00937-1
  • 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
    Omrix biopharmaceuticals has identified that there may be pressure regulators in the field with an incorrect connector type. a nitrous oxide connector has been supplied instead of a carbon dioxide connector (sis-co2 connector). the connector has a different colour (grey and not green-grey, as should be according to the australian standard- as 2896- for medical gas systems ) and in addition, instead of carbon dioxide, it was engraved with “nitrous oxide’’. johnson & johnson medical pty limited (jjm) is recalling omrix pressure regulators. the nitrous oxide inlet connector is not compatible with carbon dioxide source connector and can therefore not connect to omrix pressure regulator.
  • Action
    Johnson & Johnson Medical Pty Limited is requesting the customers to quarantine the affected pressure regulators. Arrangements will be made for a courier to pick up the affected product and a credit note issued. This action has been closed-out on 22/03/2016.

Device

Omrix Pressure Regulator (Surgical air pipeline regulator)
  • Model / Serial
    Omrix Pressure Regulator (Surgical air pipeline regulator)Product Codes: EVRC68 and EVR54CARTG Number: 203072
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd