Events

Safety Alert Or Field Safety Notices for Adaptors for Shelfpak humidifier and Aquapak sterile water

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/2014/023
  • Event Number
    CON426887
  • Date
    2014-06-17
  • Event Date Posted
    2014-06-17
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON426887?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
    The packaging of these devices might not be sealed properly. however, the adaptors are used as part of a non-sterile system, so there is limited risk to patients. teleflex published a field safety notice recalling affected products in april 2014 but has not had sufficient confirmation from users that they have received and acted upon this information.
  • Action
    Identify the affected devices using the FSN and quarantine them. Return affected devices and arrange for replacements from Teleflex. Return the acknowledgement form to the manufacturer. Action by: All staff who use these devices.

Device

Adaptors for Shelfpak humidifier and Aquapak sterile water
  • Model / Serial
  • Product Description
    Adaptors for Shelfpak humidifier and Aquapak sterile water. Specific product and lot numbers. The adaptors may be sold separately or with the Aquapak sterile water.
  • Manufacturer
    Teleflex Medical

Manufacturer

Teleflex Medical