Events

Safety Alert for Sterile Hypodermic syringe for single-use manual - without needle .. Lot: 1883G

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
    1426
  • Date
    2014-09-10
  • 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
    Determine, as a measure of sanitary interest, throughout the national territory, the suspension of the distribution, trade and use of lot 1883G (val .: 06/2018) of the product SINGLE HYPODERMIC SINGLE SYRINGE FOR MANUAL USE - NEEDLE, manufactured by Company Saldanha Rodrigues Ltda.
  • Reason
    One-sample tax report, issued by the oswaldo cruz foundation's national health quality control institute, considered unsatisfactory in the analysis of appearance, in which a hole was found in a primary package, impacting the sterility of the product, and was observed, still, the presence of whitish spots in the inner part of the cylinder of nine units.
  • Action
    Determine to the manufacturer company the collection of existing stock in the market, related to lot 1883G (val .: 06/2018)

Device

Sterile Hypodermic syringe for single-use manual - without needle .. Lot: 1883G

Manufacturer

Saldanha Rodrigues Ltda.