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 AngioDynamics.

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 027 07 12 000
  • Event Initiated Date
    2012-07-10
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=5&rid=2051
  • 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
    A potential for the product to be mislabeled. the outer box is labeled as soft-vu® angiographic catheter, jb (1) non-braided 5f x 100cm x .035”; however, the potential exists that the pouch within may be labeled as a soft-vu® angiographic catheter kerns with (1) side hole braided 4f x 65cm x .035”.

Device

Catheters, Soft-Vu Angiographic Catheter
  • Model / Serial
    Product Description ( CatalogNumber, Lot Number): Soft-Vu® Angiographic Catheter JB(1) Non-Braided 5F x 100cm x 0.035” (10734201, 564325)
  • Product Description
    Catheters, Cardiac, Angiography
  • Manufacturer
    AngioDynamics

Manufacturer

AngioDynamics
  • Manufacturer Parent Company (2017)
    AngioDynamics Inc.
  • Manufacturers representative
    Al Hammad Medical Services, Riyadh, (01) 4659811
  • Source
    SFDA