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 Hospira 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 051 09 13 000
  • Date de mise en oeuvre de l'événement
    2013-09-10
  • 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=4356
  • 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
    Hospira has become aware that customers may be inappropriately using incorrectly sized receptal liners with receptal canisters (e.G. 1.5l liner, 2l liner or 3l liner with a 1l canister). it is possible that if the incorrectly sized liners are used with different size canisters, the lid may not fit and the vacuum/suction will not be sufficient and/or consistent. to date, hospira has received reports associated with this practice, including one that resulted in a serious injury and one that resulted in a death, and recommends against this practice.

Device

Receptal System Liners and Canisters
  • Modèle / numéro de série
    List Number : ( Product Description ); 77042, 43449, 43423-8911, 43445-6111, 43503-6118 : ( Abbott canister, 1L canister, 1.5L canister, 2L canister, 3L canister )(respectively). See attached for full list
  • Description du dispositif
    It is a closed disposable suction system that is used to remove waste, blood or other fluids during surgeries or to clear patient airways, throat or wounds to allow treatment
  • Manufacturer
    Hospira Inc

Manufacturer

Hospira Inc
  • Société-mère du fabricant (2017)
    Pfizer
  • Représentant du fabricant
    AL-KAMAL Import, Riyadh, (01) 2181122
  • Source
    SFDA