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 Baxter Healthcare.

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 120 01 15 001
  • Event Initiated Date
    2015-01-27
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=7104
  • 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
    Baxter healthcare corporation received complaints indicating that the sponge of the minicap was fully separated from the cap, partially protruding from the cap or missing from the cap. use of minicaps with sponges fully separated or missing from the caps may compromise the ability of the minicap to provide a sterile barrier protection at the end of the tip of the transfer set, when the patient is not performing a therapy. this may increase the risk of peritonitis.

Device

MiniCap with Povidone-Iodine Solution
  • Model / Serial
    Product code: SPC4466 Lot numbers: All non-expired lots. ..................... NCMDR update code Product code : (Lot No.) ; 5C4466P : (GD897157), BEPC4466 : (13J23H15), SPC4466 : (14B23H15)
  • Product Description
    Transfer Sets, Continuous Ambulatory Peritoneal Dialysis
  • Manufacturer
    Baxter Healthcare

Manufacturer

Baxter Healthcare
  • Manufacturer Parent Company (2017)
    Baxter International
  • Manufacturers representative
    Arabian Health Care Supply Co. (AHCSC), Riyadh (01) 4747444
  • Source
    SFDA