Events

Safety Alert Or Field Safety Notices for Rusch Belly Bag urine collection bag with hip belt

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 Teleflex Medical.

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/2013/038
  • Event Number
    CON286861
  • Date
    2013-06-12
  • Event Date Posted
    2013-06-12
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON286861?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
    Packaging may be compromised and therefore the sterility of the product cannot be guaranteed. if non-sterile products are used, there is a risk of infection.
  • Action
    Identify and quarantine affected products. Contact patients who have received affected stock and retrieve any unused devices. Teleflex Medical issued a Field Safety Notice (FSN) on 27 March 2013 recalling all batches of the affected product codes. Return the acknowledgement form to Teleflex and arrange for the return and replacement of unused affected devices. Personnel involved in the purchase, supply and distribution of these devices.

Device

Rusch Belly Bag urine collection bag with hip belt
  • Model / Serial
  • Product Description
    Rusch Belly Bag urine collection bag with hip belt. Specific product codes. All lot numbers of the following product codes are affected: Belly Bag, product code B1000 (NHS Supply Chain code GDW502) Belly Bag with 24 inch drain, product code B1000CT Belly Bag with sample port, product code B1000P
  • Manufacturer
    Teleflex Medical

Manufacturer

Teleflex Medical