Events

Safety Alert for (1) 1G GEL-FOAM PITCH WITH HEMOSTATIC POWDER; GAZES WITH STEREO GEL-FOAMS OF SIZES: (2) 12-7MM, (3) 2CM, (4) DENTAL PACKAGES 4CM. ALL NUMBERS OF LOTS (> 1.5 MILLION DISTRIBUTED SINCE 1995 IN BRAZIL AND WORLDWIDE

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

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
    13
  • Date
    2001-03-14
  • 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
    Aluminum filiformes fragments of potes beads were detected on powder and gazes.
  • Action
    THE MANUFACTURER STARTED WITHDRAWAL ON NOVEMBER 17, 2000. RELEVANT ESTABLISHMENTS AND PROFESSIONALS SHOULD CHECK THAT THEY RECEIVED THE NOTIFICATION OF THE PHARMACY. YOU MUST IDENTIFY AND REMOVE THE AFFECTED PRODUCTS FROM YOUR INVENTORY. FOR FURTHER INFORMATION, TELEPHONE TO PHARMACY, 00XX1 (908) 901-8000.

Device

(1) 1G GEL-FOAM PITCH WITH HEMOSTATIC POWDER; GAZES WITH STEREO GEL-FOAMS OF SIZES: (2) 12-7MM, (...

Manufacturer

PHARMACIA CORP.
  • Source
    ANVSANVISA