Events

Recall of Fischer Cone Biopsy ExcisorSize medium (5/box)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Life Healthcare 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-00308-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2018-04-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00308-1
  • 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
    Finished product in lot number 212074 was identified to have been incorrectly labelled. the label incorrectly indicates the part number used for large size instead of the medium size excisor. this discrepancy does not meet the product release specifications.
  • Action
    Customers are asked to isolate these items and place affected units in the supplied plastic bag for collection by LifeHealthcare. Replacement stock will be provided in due course. A copy of the Reply Form attached to the Customer Letter should be returned by fax or email and also be enclosed with the stock to be returned.

Device

Fischer Cone Biopsy ExcisorSize medium (5/box)
  • Model / Serial
    Fischer Cone Biopsy ExcisorSize medium (5/box)Part Number: AP-900-151 Lot Number: 212074ARTG Number: 215626(Life Healthcare - Electrode, electrosurgical, active, foot-controlled, single use)
  • Manufacturer
    Life Healthcare Pty Ltd

Manufacturer

Life Healthcare Pty Ltd