Events

translation missing: fr.activerecord.attributes.event.titles.recall_field_safety_notice

Selon Saudi Food & Drug Authority, ce/cet/cette translation missing: fr.activerecord.attributes.event.types.recall_field_safety_notice concerne un dispositif en/au/aux/à Saudi Arabia qui a été fabriqué par Stryker.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Recall / Field Safety Notice
  • ID de l'événement
    mdprc 028 11 15 000
  • Date de mise en oeuvre de l'événement
    2015-11-08
  • Pays de l'événement
    Saudi Arabia
  • Source de l'événement
    SFDA
  • URL de la source de l'événement
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=8458
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Cause
    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
  • Modèle / numéro de série
    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 )
  • Description du dispositif
    Pop-up Push Handles, Surgical Accessory Rail
  • Manufacturer
    Stryker

Manufacturer

Stryker
  • Société-mère du fabricant (2017)
    Stryker
  • Représentant du fabricant
    Al-Faisaliah Medical System
  • Source
    SFDA