Events

Safety Alert for CARDIOPLEGIA CANNES SARNS. Models: 203895, 203861 and 203887. Registry Anvisa: 80012280008. See list of affected lots in the Alert Message published by the company, available at http://portal.anvisa.gov.br/wps/wcm/connect/7c2181004c05651f8c4ddcdc39d59d3e/Message + of + Alert + 1150.pdf? MOD = AJPERES.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by TERUMO MEDICAL DO BRASIL LTDA.

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
    1150
  • Date
    2012-07-17
  • 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
    Additional information in the Alert Message disclosed by the company, available at http://portal.anvisa.gov.br/wps/wcm/connect/7c2181004c05651f8c4ddcdc39d59d3e/Message+of+Alerta+1150.pdf?MOD=AJPERES. #### Update (01/11/2012): The company reported having located 296 affected units of the product remaining in the market. The date of destruction of these collected units will still be confirmed by the company. #### Update (09/04/2013): The field action was completed by the record holder on 11/27/2012. There were collected 276 units of product under risk, which were destroyed according to Certificates of Treatment presented by Terumo Medical do Brasil Ltda.
  • Reason
    Presence of foreign substance on surface of product.
  • Action
    It is a collection of product, aiming at its destruction. Check in your stock if you have products affected by this field action. If so, segregate and identify them to avoid inadvertent use, complete and submit the Response Form provided by Terumo and contact the company to receive instructions for the referral of the segregated products.

Device

CARDIOPLEGIA CANNES SARNS. Models: 203895, 203861 and 203887. Registry Anvisa: 80012280008. See l...

Manufacturer

TERUMO MEDICAL DO BRASIL LTDA