Events

Safety Alert for 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

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by KENDALL CO A TYCO HEALTHCARE GROUP CO.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    122
  • Date
    2000-03-31
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Reason
    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