Events

Recall of Medicina Nasogastric Tubes

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Australasian Medical & Scientific 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-00269-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-04-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00269-1
  • 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
    Australasian medical & scientific ltd (amsl) have been made aware that the measurement markings on certain nasogastric tubes may be blurred and illegible which may result in a tube being inserted at an incorrect length in a patient.
  • Action
    AMSL is advising customers to inspect inventory for identified lot numbers and inspect these lots for any units which display blurry or illegible text. Users should quarantine any affected units for return to AMSL and a replacement to be issued.

Device

Medicina Nasogastric Tubes
  • Model / Serial
    Medicina Nasogastric TubesProduct Codes: LG & NGPTube sizes: 4Fr, 5Fr and 6FrMultiple Lot NumbersARTG Number: 276654(Australasian Medical & Scientific - Tube, feeding, nasoenteral)
  • Manufacturer
    Australasian Medical & Scientific Ltd

Manufacturer

Australasian Medical & Scientific Ltd