Events

Avis De Sécurité sur STERILE WINDING 18G

Selon Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Slovenia 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
    Field Safety Notice
  • Date
    2016-06-03
  • Pays de l'événement
    Slovenia
  • Source de l'événement
    AMPMDRS
  • Notes / Alertes
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Notes supplémentaires dans les données
  • Cause
    Kimal received a complaint from one party that the above product was inconsistent when sealing the bag. after an internal inspection of the stored specimens, we identified some instances where the pouch was not sealed in the corner where it normally opens, meaning that the product is no longer sterile. we kindly ask you to review your stock of the above mentioned product and batch numbers. if you find that the bag is not sealed, remove the product in question from your stock and discard it. tell kimal how many products you have discarded and you will receive free replacement items. the photos below show a seal error and acceptable seal:.

Device

STERILE WINDING 18G
  • Modèle / numéro de série
  • Manufacturer
    Kimal Plc

Manufacturer

Kimal Plc