Events

Safety Alert Or Field Safety Notices for Solus Flexible Wire Reinforced Laryngeal Mask Airway

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by Intersurgical.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Safety alert / Field Safety Notice
  • Date
    2017-06-09
  • Event Date Posted
    2017-06-09
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://www.gov.uk//drug-device-alerts/solus-flexible-wire-reinforced-laryngeal-mask-airway-risk-of-hypoxia-due-to-partial-or-total-occlusion-of-the-airway-tube-after-inflating-the-cuff
  • Notes / Alerts
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Extra notes in the data
  • Reason
    Manufactured by intersurgical – due to a manufacturing fault, inflation of the cuff may reduce the airway tube cross-section, leading to partial or total occlusion of the airway and reduced air flow to the patient.
  • Action
    Identify affected devices (see below) and stop using them. Quarantine and destroy all affected devices in stock. Contact Intersurgical to acknowledge receipt of the Field Safety Notice (dated 28 March 2017) even if you don’t have affected devices left in stock.

Device

Solus Flexible Wire Reinforced Laryngeal Mask Airway
  • Model / Serial
  • Product Description
    The following models and LOT numbers are affected:Solus Flexible, small paediatric, wire-reinforced laryngeal mask airway 2 Solus Flexible, large paediatric, wire-reinforced laryngeal mask airway 2.5 Solus Flexible, small adult, wire-reinforced laryngeal mask airway 3 Solus Flexible, medium adult, wire-reinforced laryngeal mask airway 4 Solus Flexible, large adult, wire-reinforced laryngeal mask airway 5LOT numbers: from 31310139 to 31703855 inclusive.REF numbers NHS Supply Chain Codes Scottish NDC Codes 8002001 FDD1640 n/a 8025001 FDD1641 n/a 8003001 FDD1642 NDC SKU 057290 8004001 FDD1643 NDC SKU 057306 8005001 FDD1644 n/a
  • Manufacturer
    Intersurgical

Manufacturer

Intersurgical
  • Manufacturer Address
    Intersurgical Ltd Telephone: 0118 9656 300 Fax: 0118 9656 356Email: info@intersurgical.co.uk
  • Manufacturer Parent Company (2017)
    Etablissement Cosmeplast
  • Source
    MHRA