Events

Safety Alert Or Field Safety Notices for RÜSCH Macintosh laryngoscopes

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/2013/034
  • Event Number
    CON273712
  • Event Date Posted
    2013-05-15
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON273712?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 flicker or fail during intubation due to a loose connection between the battery and the battery cap.
  • Action
    Identify, quarantine and do not use affected devices. Follow the advice in the M.A. Arain Field Safety Notices for either disposable or reusable products (both dated 15 March 2013). Contact Teleflex to arrange for devices to be exchanged or to confirm that you have none in stock.

Device

RÜSCH Macintosh laryngoscopes
  • Model / Serial
  • Product Description
    RÜSCH Macintosh laryngoscopes. Disposable laryngoscope metal kit, disposable laryngoscope battery handles and reusable laryngoscope handles. Distributed in the UK by Teleflex (RÜSCH). Specific lot numbers are affected. Disposable laryngoscope metal kit, catalogue numbers: 670160-0000** and 670190-0000** Disposable laryngoscope battery handles, catalogue numbers: 670195-0000** Reusable laryngoscope handles, catalogue numbers: 670067-0000** ** relates to blade size. The lot numbers of affected products are as follows: Disposable Reusable 031511 031511 040811 041511 041511 040811 011012 123011 020712 011012 021512 030812 030812 032112 032112 073012 040412 083112 040912 103112 042712 111512 052912 Any product without a visible lot number should be treated as an affected product.
  • Manufacturer
    M.A. Arain & Brothers (PVT) Ltd

Manufacturer

M.A. Arain & Brothers (PVT) Ltd