Events

Safety Alert for Tubes, blood collection, Plasma Separator Tubes Vacutainer Plus 45 ml 13 x 100. catalog number: 367962; Number of lots: 1008353

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

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
    331
  • Date
    2001-11-09
  • 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
    Some of the tubes above did not have the required amount of lithium heparin. the distributor started the removal by letter dated august 17, 2001.
  • Action
    Check out BD Vacutainer Systems has already contacted you. Identify and isolate all affected products in your inventory. For more information, contact your local representative or directly with BD Vacutainer Systems at (888) 237-2762 in the United States. ANVISA is interested in following if there was good collaboration of the distributor with its laboratory. Notify any occurrences associated with these products, to ANVISA, Technovigilance Unit, filling out the Health Product Associated Notifications Form available on the Internet http://www.anvisa.gov.br/tecnovigilancia and send directly online or save the file completed and send by e-mail tecnovigilância@anvisa.gov.br, or print it and send it by fax 0xx61-4481257.

Device

Tubes, blood collection, Plasma Separator Tubes Vacutainer Plus 45 ml 13 x 100. catalog number: 3...

Manufacturer

BD Vacutainer Systems Div BD
  • Source
    ANVSANVISA