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 101 03 12 000
  • Event Initiated Date
    2012-03-25
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=5&rid=1619
  • 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: NCAR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Reason
    Hospira, inc. has received customer reports of bolus delivery failures when using the gemstar bolus cord. possible failures may be a result of cracked or damaged bolus cords which may result in an open or short circuit of the bolus cord. potential risk due to failure of the bolus cord is the potential for an unrequested bolus delivery or the failure to deliver requested medication to the patient. the amount of unrequested delivery will be limited by programming lockout volumes. an unrequested narcotic delivery may cause over sedation requiring possible medical intervention, but is unlikely to result in serious or life threatening injuries. the failure to deliver requested narcotic medication may result in the lack of adequate pain relief.

Device

Infusion pump, GemStar Bolus Cord
  • Model / Serial
    List Number 13027 Serial no.: All Lot/batch no.: All
  • Product Description
    Infusion pump, Bolus Cord, delivery
  • Manufacturer
    Hospira Inc

Manufacturer

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