Events

Safety Alert for Irrigation Tray: (1) Bardia, (2) Bulb, (3) Gent-L-Kare with 60cc Bulb Syringe. Catalog #: (1) 802050, (2) 750170, (3) 4092; Lot #: (1 and 2) all numbers, (3) batches starting with MF, MH, N, P, R, S, T and U.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Premium Plastics Inc, Bard Medical Div C R Bard 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
    398
  • Date
    2002-02-22
  • 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
    In the tray above, the package can be damaged, compromising the sterility of the syringe kits. the manufacturer initiated withdrawal by letter on 16 november 2001.
  • Action
    Make sure you received the letter dated November 16, 2001 from Premium Plastics. Identify and isolate any affected product in your inventory. For more information, contact Premium Plastics by phone at (312)255-8700 or your local Premium Plastics representative. For further information, please contact ANVISA's Tecnovigilância Unit, by e-mail tecnovigilancia@anvisa.gov.br or by telephone (61) 448-1485

Device

Irrigation Tray: (1) Bardia, (2) Bulb, (3) Gent-L-Kare with 60cc Bulb Syringe. Catalog #: (1) 802...

Manufacturer

Premium Plastics Inc, Bard Medical Div C R Bard Inc
  • Source
    ANVSANVISA