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 Hospira 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 049 09 12 000
  • Event Initiated Date
    2012-09-09
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=2303
  • 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
    Visible particles embedded in the glass identified during a retain sample inspection. there may be the potential for product to come into contact with the embedded particles and the particles may become dislodged into the solution.

Device

Medicine Bottles, Empty Evacuated Containers
  • Model / Serial
    Empty Evacuated Containers (List Nos.; Lot Nos.); (1) 250 mL (1614-02; 11179DW EXP NOV 1 2013, 11195DW EXP NOV 1 2013, 93854DW EXP SEP 1 2012); (2) 1,000 mL (1614-05; 92835DW EXP AUG 1 2012, 96090DW EXP DEC 1 2012, 96098DW EXP DEC 1 2012)
  • Product Description
    Medicine Bottles
  • Manufacturer
    Hospira Inc

Manufacturer

Hospira Inc
  • Manufacturer Parent Company (2017)
    Pfizer
  • Manufacturers representative
    AL-KAMAL Import, Riyadh, (01) 2181122
  • Source
    SFDA