Events

Safety Alert Or Field Safety Notices for RUSCH Mackintosh laryngoscope disposable metallic kit

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 M.A. Arain & Brothers (PVT) Ltd.

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
  • Event ID
    MDA/2012/032
  • Event Number
    CON155659
  • Date
    2012-06-12
  • Event Date Posted
    2012-06-12
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON155659?tabName=allTabs
  • 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
    There is potential for the light to fail during intubation due to a loose connection between the battery and the battery cap.
  • Action
    Identify, quarantine and do not use devices from the affected batches. Contact Teleflex to arrange for devices to be exchanged or to confirm that you have none in stock. Follow the advice in the Teleflex Field Safety Notice (dated 29 May 2012).

Device

RUSCH Mackintosh laryngoscope disposable metallic kit
  • Model / Serial
  • Product Description
    RUSCH Mackintosh laryngoscope disposable metallic kit (all sizes). Catalogue numbers: 670160-0000** (** relates to blade size). Batch numbers 041511 and 021512. Distributed in the UK by Teleflex (RUSCH). These laryngoscope handles are found in the RUSCH Mackintosh laryngoscope disposable metallic kit (all sizes) – ensure both components of the kit are returned to Teleflex. Teleflex issued a Field Safety Notice on 29 May 2012 regarding this product recall. M.A. Arain & Brothers (PVT) Ltd issued two of their own Field Safety Notices, published in April and May 2012.
  • Manufacturer
    M.A. Arain & Brothers (PVT) Ltd

Manufacturer

M.A. Arain & Brothers (PVT) Ltd