Events

Recall of Cook Aspiration Unit

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by William A Cook 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-00174-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-02-26
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00174-1
  • 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
    A recent design review of the k-mar-5200 aspiration unit, identified that the internal mains wiring does not fully comply with the requirements of the medical electrical equipment standard iec60601-1 edition 3.0. iec60601-1. this standard states that conductors and connectors of medical electrical equipment shall be secured or insulated so that accidental detachment shall not result in a hazardous situation. the k-mar-5200 mains wiring is secured, but the mechanism is not considered suitable under iec60601-1.To date, no harm has been reported as a result of this issue.
  • Action
    Cook Medical is advising that they will be replacing the mains wiring for affected each unit. An authorised service agent will contact users to arrange for impacted devices to be corrected. In the interim, Cook Medical recommends that a residual current device (RCD), also known as a ground fault circuit interrupter (GFCI), ground fault interrupter (GFI), or an appliance leakage current interrupter (ALCI) is fitted to the mains electricity supply to mitigate the risk of a hazardous situation.

Device

Cook Aspiration Unit
  • Model / Serial
    Cook Aspiration Unit Part Numbers: K-MAR-5200, K-MAR-5200-USGlobal Product Numbers: G49275, G51067ARTG Number:156032(William A Cook Australia - Suction unit, electric powered)
  • Manufacturer
    William A Cook Australia Pty Ltd

Manufacturer

William A Cook Australia Pty Ltd