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 DeRoyal Industries Inc..

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 138 07 16 000
  • Date de mise en oeuvre de l'événement
    2016-07-21
  • 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=9722
  • 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
    The issue reported and confirmed is that the product labeling for this lot states the product lot is sterile, however there is also a statement on the product labeling which states "non-sterile". the product is mislabeled, the error is that the product labeling states "non-sterile". upon investigation of this report, deroyal confirmed that this product, isolation bag 30-5510, is required to be sterilized with ethylene oxide gas during the operational processes at deroyal prior to release.

Device

DeRoyal Isolation Bag
  • Modèle / numéro de série
    The lot affected was manufactured on production work order 14097259
  • Description du dispositif
    Descriptor- lntraoperative Procedure Bag
  • Manufacturer
    DeRoyal Industries Inc.

Manufacturer

DeRoyal Industries Inc.