Events

Safety Alert for PROCIDE-D PLUS DISINFECTANT AND STERILIZING SOLUTIONS

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by METREX DIV SYBRON DENTAL SPECIALTIES 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
    163
  • Date
    2000-10-27
  • 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
    Part of the lots of the products mentioned have been incorrectly labeled as procide-d plus, which contains 3.4% glutaraldehido, other than procide-d, which contains 2,5% glutaraldehido. syron dental specialties began a correspondence removal dated 7 august 2000. the firm has provided no information to ecri.
  • Action
    MAKE SURE THAT YOU HAVE RECEIVED THE CORRESPONDENCE OF 7 AUGUST 2000 SUBMITTED BY SYBRON DENTAL SPECIALTIES. IDENTIFY AND ISOLE ANY PRODUCT AFFECTED FROM YOUR INVENTORY. FOR FURTHER INFORMATION, PLEASE CONTACT YOUR LOCAL REPRESENTATIVE OR DIRECTLY WITH SYBRON DENTAL SPECIALTIES BY PHONE 1 (800) 841-1428.

Device

PROCIDE-D PLUS DISINFECTANT AND STERILIZING SOLUTIONS

Manufacturer

METREX DIV SYBRON DENTAL SPECIALTIES INC
  • Source
    ANVSANVISA