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 Advanced Sterilization Products.

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 016 05 12 000
  • Date de mise en oeuvre de l'événement
    2012-05-06
  • 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=1797
  • 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
    This letter applies to all lots of glosair™ 400 cartridges (cartridges) shipped within the past year that indicate a storage temperature of 5º - 40ºc. asp has recently determined that the cartridges, if stored at the upper extreme of the permitted labeled temperature requirements, may not meet product specifications for end of shelf life. while you can be assured that this presents no health risk, in keeping with our commitment to provide customers with quality products, asp has voluntarily decided to recall the product, and will be correcting future product to reflect the appropriate storage conditions and shelf life.

Device

Cleaning, GLOSAIR™ 400 Cartridges

Manufacturer

Advanced Sterilization Products
  • Société-mère du fabricant (2017)
    Johnson & Johnson
  • Représentant du fabricant
    FAROUK, MAAMOUN TAMER & COMPANY, Riyadh, (01) 4142200
  • Source
    SFDA