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 DeRoyal Industries 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 138 07 16 000
  • Event Initiated Date
    2016-07-21
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=9722
  • 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
    The issue reported and confirmed is that the product labeling for this lot states the product lot is sterile, however there is also a statement on the product labeling which states "non-sterile". the product is mislabeled, the error is that the product labeling states "non-sterile". upon investigation of this report, deroyal confirmed that this product, isolation bag 30-5510, is required to be sterilized with ethylene oxide gas during the operational processes at deroyal prior to release.

Device

DeRoyal Isolation Bag
  • Model / Serial
    The lot affected was manufactured on production work order 14097259
  • Product Description
    Descriptor- lntraoperative Procedure Bag
  • Manufacturer
    DeRoyal Industries Inc.

Manufacturer

DeRoyal Industries Inc.