Events

Safety Alert for (1) BIO-MEDICUS FEMURAL CANCER WITH ADVANTAGE GUIDES FOR ADULTS AND MEDIUM INCHES, BIO-MEDICUS PERCUTANEOUS FEMALE CANCER KITS: (2) BLOODY, (3) VENOUS. WE. OF THE PRODUCTS (1) 96370-023, 025, 027, 029, (2) 96530-015, 017, 019, 021, (3) 96600-015, 017, 019, 021.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by MEDTRONIC INC.

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
    60
  • Date
    2001-03-14
  • 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
    Possible insertion difficulty of the recommended 0.038 inch guide at the terminal point of the introduction guide.
  • Action
    THE MANUFACTURER STARTED WITHDRAWAL ON 22 / SEPTEMBER / 2000. RELEVANT ESTABLISHMENTS AND PROFESSIONALS SHOULD CHECK THAT THEY RECEIVED MEDTRONIC NOTIFICATION. YOU SHOULD IDENTIFY, REMOVE FROM THE USE, YOUR INVENTORY AND RETURN THE AFFECTED PRODUCTS AS INDICATED IN THE MANUFACTURER'S LETTER. FOR FURTHER INFORMATION, TELEPHONY TO CHRIS CAMPBELL-LOTH, MEDTRONIC, 00XX1 (763) 514-8547.

Device

(1) BIO-MEDICUS FEMURAL CANCER WITH ADVANTAGE GUIDES FOR ADULTS AND MEDIUM INCHES, BIO-MEDICUS PE...

Manufacturer

MEDTRONIC INC
  • Source
    ANVSANVISA