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 Kimal plc.

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 026 05 15 001
  • Date de mise en oeuvre de l'événement
    2015-06-03
  • 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=7732
  • 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, MHRA
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Cause
    The light glove may contain splits or holes or be torn.

Device

Devon Light Glove included in various Kimal Procedure Packs
  • Modèle / numéro de série
    Product Description: PSCC PAEDIATRIC ANGIO PACK Product Code: SA-K20380 Product Description: PSCC PAEDIATRIC ANGIO PACK Product Code: SA-K20380/P1 Product Description: KFMC PAEDIATRIC PACK Product Code: SA-K41949/P1 Product Description: KKNGH CARDIOLOGY PACING PACK Product Code: SA-K42117 Product Description: KKNGH REVEAL PACK Product Code: SA-K42118 Product Description: PSCC PAEDIATRIC ANGIO PACK Product Code: SA-K43714 Product Description: CAESARIAN-SECTION PACK PSCC Product Code: SPR/9911/45035 Product Description: KFNGH PAEDIATRIC CATH LAB PACK Product Code: SPR/9964/41494 Product Description: KFNGH ADULT CATH LAB PACK Product Code: SPR/9964/41495 Product Description: PSCC PAEDIATRIC ANGIO PACK Product Code: SPR/9964/42508 Product Description: KKUH PAEDIATRIC ANGIO PACK Product Code: SPR/9964/42865 Product Description: PSCC PAEDIATRIC ANGIO PACK Product Code: SPR/9964/43714 Product Description: PSCC PAEDIATRIC ANGIO PACK Product Code: SPR/9964/45033 Lot Numbers : Please see attached ..................... MHRA update code Multiple products and Lot numbers of the affected device are provided in the attached FSN.
  • Description du dispositif
    This product is a disposable cover used in operating rooms
  • Manufacturer
    Kimal plc

Manufacturer

Kimal plc