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 Stryker.

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 028 11 15 000
  • Event Initiated Date
    2015-11-08
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=8458
  • 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
    It was identified by a customer complaint that some i.V. poles were retracting/lowering from an extended position to the low height unexpectedly. an investigation was initiated which identified that the i.V. latch housing was nonconforming.

Device

Stryker 2-Stage and 3-Stage I.V. Poles
  • Model / Serial
    Manufacturer Model Number # 2035-112-010 Product Description : Head End Left, 2 Stage I.V. Pole Manufacturer Model Number # 2035-113-011 Product Description : Head End Right, 2 Stage I.V. Pole Manufacturer Model Number # 0785-035-101 Product Description : 26", 2 Stage IV Pole Assembly Manufacturer Model Number # 0785-035-200 Product Description : 26", 3 Stage IV Pole Assembly Manufacturer Model Number # 0785-035-300 Product Description : 30", 3 Stage IV Pole Assembly Manufacturer Model Number # 0785-035-401 Product Description : 30", 2 Stage IV Pole Assembly For I.V. Pole option numbers ship as service kits. ( Please see attachment )
  • Product Description
    Pop-up Push Handles, Surgical Accessory Rail
  • Manufacturer
    Stryker

Manufacturer

Stryker
  • Manufacturer Parent Company (2017)
    Stryker
  • Manufacturers representative
    Al-Faisaliah Medical System
  • Source
    SFDA