Events

Avis De Sécurité sur Fem-Flex II Femoral Arterial Cannula

Selon ALIMS (Agencija za lekove i medicinska sredstva), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Serbia qui a été fabriqué par EDWARDS LIFESCIENCES.

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
    Field Safety Notice
  • Date de publication de l'événement
    2014-05-06
  • Pays de l'événement
    Serbia
  • Source de l'événement
    ALIMSA
  • URL de la source de l'événement
    https://www.alims.gov.rs/latin/2014/05/06/obavestenje-o-meri-povlacenja-sa-trzista-medicinskog-sredstva-fem-flex-ii-femoral-arterial-cannula/
  • Notes / Alertes
    Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), 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 Serbia.
  • Notes supplémentaires dans les données
  • Cause
    The manufacturer has received five reports in the last four months involving the separation of dilator tips on specific models of fem-flex ii arterial cannula sizes 16, 18 and 20 french. some of the reporeted vevents invovled separation of the tip of the dilator required through an interventional radiologic procedure. it was first reported in december of 2016 for lots manufacturet as early as march, 2011. the investigation determined that the dilator made specifically for the 16, 18 and 20 french sizes presented a hazard during use. based on the potential impact to patients, edwards is recalling the 16, 16 and 20 french sizes of the fem-flex ii aretrial cannulae that have not expired.

Device

Fem-Flex II Femoral Arterial Cannula
  • Modèle / numéro de série
    16 - DFEMII016AS, DIIFEMII016A, FEMII016A, FEMII016AS; 18 - DFEMII018AS, DIIFEMII018A, FEMII018A, FEMII018AS; 20 - DFEMII020AS, DIIFEMII020A, FEMII020A, FEMII020AS
  • Manufacturer
    EDWARDS LIFESCIENCES

Manufacturer

EDWARDS LIFESCIENCES