Events

Recall of OM040R - Doyen-Collin Mouth Gag 120mm Produced between Feb 2016 and Oct 2017 inclusive

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by B Braun 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-2018-RN-00124-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2018-03-14
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00124-1
  • 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
    Braun has been notified by the manufacturer that an error in the initial manufacture of these items has been identified resulting in a potential for the protective sleeves to become “sticky” after reprocessing.It has been determined that the used plastic sleeves of the instrument do not meet the valid specification. instead of the specified material silicone, the material pvc was used for the manufacturing of the sleeves. this could render affected instruments unusable after reprocessing.
  • Action
    B Braun is advising users to ensure that the affected products are no longer used and to complete and fax the Facsimile Reply Form provided with the Customer Letter to them so that they may arrange for devices to be collected and repaired.

Device

OM040R - Doyen-Collin Mouth Gag 120mm Produced between Feb 2016 and Oct 2017 inclusive
  • Model / Serial
    OM040R - Doyen-Collin Mouth Gag 120mmProduced between Feb 2016 and Oct 2017 inclusiveARTG Number: 99164
  • Manufacturer
    B Braun Australia Pty Ltd

Manufacturer

B Braun Australia Pty Ltd