Events

translation missing: en.activerecord.attributes.event.titles.recall_field_safety_notice

According to Saudi Food & Drug Authority, this translation missing: en.activerecord.attributes.event.types.recall_field_safety_notice involved a device in Saudi Arabia that was produced by Fisher & Paykel Healthcare Inc.

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
    Recall / Field Safety Notice
  • Event ID
    mdprc 054 10 17 001
  • Event Initiated Date
    2017-10-17
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=11640
  • Notes / Alerts
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
  • Extra notes in the data
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Reason
    Fph is issuing this voluntary recall notice due to an increased rate of split tubing cuffs in catheter mounts manufactured on specific dates.

Device

Catheter Mount Split Tubing Cuff
  • Model / Serial
    Model: RT021 From Lot 2100089358 to Lot 2100098462 and From Lot 2100190360 to Lot 2100241254 ------------------------------------------------------------------------------- BfArM Update codes: Model Number (REF): RT443 Affected Lot Numbers (LOT): From Lot 2100089390 to Lot 2100233760
  • Product Description
    Heated Humidifier
  • Manufacturer
    Fisher & Paykel Healthcare Inc

Manufacturer

Fisher & Paykel Healthcare Inc