Events

Recall of Bolton Surgical - Sims Speculum D/E Insulated Large 33 x 38 mm 18.5cm

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Device Technologies 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-2012-RN-00951-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-09-21
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00951-1
  • 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
    It has been identified that there is a possible fault in the affected batches due to inadequate bonding between the coating and substrate in manufacturing, which may cause insulation to crack and lift away from the metal body.
  • Action
    Customers to identify and segregate any units from affected batch number and contact the sponsor to arrange return of recalled stock and order replacement stock.

Device

Bolton Surgical - Sims Speculum D/E Insulated Large 33 x 38 mm 18.5cm
  • Model / Serial
    Bolton Surgical - Sims Speculum D/E Insulated Large 33 x 38 mm 18.5cmProduct Code: ENG-17/1847/6Batch/Lot Number: 117696ARTG Number: 175488
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd