Events

Alerte De Sécurité sur KENDALL STERILIZED PROCESSING KITS WHICH CONTAIN CLINICALLY ANTI-SEPTIC PRODUCTS ALREADY REVISED: (1) CURITY, (2) KENDGUARD, (3) SAGE; PRIVATE LABEL STERILE (4) ALLEGIANCE, (5) SOURCE, (6) RESPIRATORY SUPPORT PRODUCTS

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par KENDALL CO A TYCO HEALTHCARE GROUP CO.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    122
  • Date
    2000-03-31
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • Notes supplémentaires dans les données
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Cause
    The above mentioned kits, kits, and tablets contain anti-sepsis products which may be contaminated by bacteria and / or antiseptic products labeled as sterile and which are not capable of ensuring their sterility. kendall began a recall through correspondence sent on march 24, 2000. the manufacturer provided no information to ecri.
  • Action
    MAKE SURE THAT YOU HAVE RECEIVED THE LETTER OF MARCH 24, 2000 AND KENDALL LABELS. IDENTIFY AND COLLECT ANY AFFECTED PRODUCT FROM YOUR INVENTORY. PUT THE LABELS ON ANY DAMAGED PRODUCT AND COLLECT / DISPOSE ANY ANTI-SEPTIC PRODUCT CLINIC OF THE KITS. FOR FURTHER INFORMATION, CONTACT KENDALL'S LOCAL CONSUMER SERVICE OR TELEPHONE 1 (508) 261-8000 IN THE UNITED STATES.

Device

KENDALL STERILIZED PROCESSING KITS WHICH CONTAIN CLINICALLY ANTI-SEPTIC PRODUCTS ALREADY REVISED:...

Manufacturer

KENDALL CO A TYCO HEALTHCARE GROUP CO
  • Source
    ANVSANVISA