Events

Safety Alert for SINGLE USE HYPODERMIC SYRINGE WITH SR NEEDLE - Registration 80026180014 - Affected Lot: 2078E

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

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
    1165
  • Date
    2012-08-17
  • 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
    Anvisa is following this action.
  • Reason
    Disapproval in the aspect and labeling trials as per report of analysis 512.1p.0 / 2012, issued by incqs on 07/13/2012.
  • Action
    Stop use; identify the product in its inventory, segregate and contact the supplier for collection and replacement.

Device

SINGLE USE HYPODERMIC SYRINGE WITH SR NEEDLE - Registration 80026180014 - Affected Lot: 2078E

Manufacturer

SALDANHA RODRIGUES LTDA.