Events

Safety Alert for Solus Flexible Wire-reinforced Laryngeal Mask Airways

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Intersurgical Ltd.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2017-03-30
  • Event Date Posted
    2017-03-30
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170330.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: intersurgical ltd solus flexible wire-reinforced laryngeal mask airways intersurgical ltd has issued a medical device safety alert concerning its solus flexible wire-reinforced laryngeal mask airways. the affected devices are identified as follows:- solus flexible, small adult, wire-reinforced laryngeal mask airway 3 solus flexible, medium adult, wire-reinforced laryngeal mask airway 4 ref numbers: 8003001, 8004001 lot numbers: 31610466 (ref number 8003001), 31612211 (ref number 8004001) the manufacturer has voluntarily initiated a global corrective action of specific product codes and associated lots of solus flexible wire-reinforced laryngeal mask airways. all other solus products are unaffected. a manufacturing fault in the tube supplied to intersurgical for production of the device 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. the outcome for the patient will depend on a number of variables, including the degree of occlusion and how quickly the source of the problem is identified allowing remedial action to be taken. an internal assessment of product performance, including a review of customer complaints has confirmed these devices represent a potentially serious risk to patient safety. for this reason and to prevent any potential risk of harm, all of the affected products must not be used and must be destroyed. affected users should take the following actions:- stop the use of all affected devices. ensure that all of the affected devices in stock are quarantined. according to the local supplier, the affected products are distributed in hong kong if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 30 march 2017.

Device

Solus Flexible Wire-reinforced Laryngeal Mask Airways
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Intersurgical Ltd Solus Flexible Wire-reinforced Laryngeal Mask Airways
  • Manufacturer
    Intersurgical Ltd

Manufacturer

Intersurgical Ltd