Events

Safety Alert Or Field Safety Notices for Reusable latex breathing bags

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 Dräger.

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/2014/016
  • Event Number
    CON416685
  • Date
    2014-05-15
  • Event Date Posted
    2014-05-15
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON416685?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
    Potential for acute allergic reaction in staff or patients after using a dräger latex breathing bag. these breathing bags are marked ‘nr’ for natural rubber (latex) but this may not be immediately obvious to the user.
  • Action
    Identify affected products – Dräger latex breathing bags are blue. Ensure all staff who use these devices are aware of the guidance in the manufacturer’s Field Safety Notice. Follow local procedures for latex.

Device

Reusable latex breathing bags
  • Model / Serial
  • Product Description
    Reusable latex breathing bags. Specific part numbers affected. The following part numbers are affected: Reusable latex breathing bags: 2165686, 2165953, 2165694, 2165708, 2165716, 2165724, 2165763, 2165775 and 2165783. Reusable latex breathing bags used with test lung: 8403201. Reusable latex breathing bags used with reusable anaesthesia sets: M33681, M27542, M34822, M34823 and M34824.
  • Manufacturer
    Dräger

Manufacturer

Dräger