Events

Recall of Ellex Prager scleral shell for Biometry and 10MHZ Biometric A Scan Probe Kit

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Ellex 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-2017-RN-00213-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2017-02-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00213-1
  • 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
    The prager shell is supplied as an accessory with the ellex ‘eyecubed v4' and ‘eyeone’ ophthalmic ultrasound diagnostic device. prager shells are reusable semi critical devices requiring high level disinfection. they are required to be cleaned and disinfected before the first use and between patient uses.An issue has been identified with the manufacturer's instructions for use (ifu) for the prager shell. this ifu does not provide adequate details on the cleaning and disinfection procedures. validated cleaning and disinfection procedures, which will provide the required level of cleaning and disinfection, have been included in a revised version of the ellex prager shell care instructions. to date, there have been no adverse events reported to ellex for the prager shells.
  • Action
    Ellex is advising customers with affected stock to ensure that cleaning and disinfection procedures of the Prager shell are performed in accordance with the “Ellex Prager Shell Care Instructions” supplied.

Device

Ellex Prager scleral shell for Biometry and 10MHZ Biometric A Scan Probe Kit
  • Model / Serial
    Ellex Prager scleral shell for Biometry and 10MHZ Biometric A Scan Probe KitEllex 14.9mm OD - Prager Adult - Prager scleral shell for BiometryModel No: P-106, PRAGERADULTLot No: AA003725, 15-385, 15-393 and 16-207Ellex 12.5mm OD - Prager Child - Prager scleral shell for BiometryModel No: P-106SV, PRAGERCHILDLot No: 15-32610 MHZ Biometric A Scan Probe Kit (includes Prager Adult)Model No: 10MHZASCAN-KITLot No: 15M028, 15L049, 15M046, 15M057 and 16K050ARTG Number: 242235
  • Manufacturer
    Ellex Medical Pty Ltd

Manufacturer

Ellex Medical Pty Ltd