Events

Recall of Solus Flexible, wire-reinforced laryngeal mask airway Small paediatric, wire-reinforced laryngeal mask airway 2 Large paediatric, wire-reinforced laryngeal mask airway 2.5 Small adult, wire-reinforced laryngeal mask airway 3 Medium adult, wire-reinforced laryngeal mask airway 4 Large adult, wire-reinforced laryngeal mask airway

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Intersurgical 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-2017-RN-00447-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2017-04-05
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00447-1
  • 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
    An internal assessment by intersurgical of product performance, including a review of customer complaints, has confirmed that specific solus flexible wire-reinforced laryngeal mask airway products have a manufacturing fault in the tube. this fault can result in partial or total occlusion of the airway tube when the cuff is inflated, which may result in partial or total restriction of air delivery to and/or from the patient.
  • Action
    Intersurgical is advising users to inspect their stocks and quarantine all units from the affected lot numbers, and to destroy these affected products. Credit will be arranged for this stock.

Device

Solus Flexible, wire-reinforced laryngeal mask airway Small paediatric, wire-reinforced laryngeal...
  • Model / Serial
    Solus Flexible, wire-reinforced laryngeal mask airwaySmall paediatric, wire-reinforced laryngeal mask airway 2Large paediatric, wire-reinforced laryngeal mask airway 2.5Small adult, wire-reinforced laryngeal mask airway 3Medium adult, wire-reinforced laryngeal mask airway 4Large adult, wire-reinforced laryngeal mask airway 5Order Codes: 8002001, 8025001, 8003001, 8004001, 8005001Lot Numbers: from 31310354 to 31700331ARTG Number: 224554
  • Product Classification
    Anesthesiology Devices
  • Manufacturer
    Intersurgical Australia Pty Ltd

Manufacturer

Intersurgical Australia Pty Ltd