Events

Safety Alert for Human Blood Vessel for Transplantation: (1) Model A020 ​​Descending thoracic aorta, (2) Model P010 Pulmonary Trunk patch, (3) Model PH00 Hemiartéria Pulmonar. Nos. Series: (1) 6489451, (2) 6489486, (3) 6489478

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by CryoLife 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
    276
  • Date
    2002-01-25
  • 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 vessels, for transplantation, were collected from a donor that was not properly evaluated. the manufacturer initiated a correction by letter dated 1st. november 2001. the firm did not give any information to ecri.
  • Action
    Make sure you received the letter dated November 1, 2001 from CryoLife. Identify and isolate any affected product in your inventory. For more information, contact CryoLife by phone at (800)438-8285.

Device

Human Blood Vessel for Transplantation: (1) Model A020 ​​Descending thoracic aorta, (2) Model P01...

Manufacturer

CryoLife Inc
  • Source
    ANVSANVISA