Events

Safety Alert for SETS, TROMBECTOMY SYSTEM WITH ANGIOJET RHEOLYTIC PUMP, LOTS NO.S 16644 A 19912

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by POSSIS MEDICAL 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
    17
  • Date
    2001-05-14
  • 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
    These pump assemblies have insufficiently lacrated external packaging, committing its sterility. the distributor began a correction by letter of december 18, 2000.
  • Action
    VERIFY THAT YOU HAVE RECEIVED THE POSSIBLE LETTER OF DECEMBER 18, 2000. IDENTIFY AND ISOLE ALL THESE PRODUCTS THAT MAY BE IN YOUR INVENTORY. FOR FURTHER INFORMATION CONTACT JAMES GUSTAFSON, AT POSSIS, BY PHONE 0021-1-763-780-4555.

Device

SETS, TROMBECTOMY SYSTEM WITH ANGIOJET RHEOLYTIC PUMP, LOTS NO.S 16644 A 19912

Manufacturer

POSSIS MEDICAL INC
  • Source
    ANVSANVISA