Events

Safety Alert for 5mL Safety Jet Safety Syringe, lot 100120 - registration no. 10369460041

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Labor Import; Anhui Tiankang Medical Products.

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
    1486
  • Date
    2014-12-15
  • 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
    According to the manifestation of the company, in compliance with RDC 23/2012, the deviation verified was punctual, there being no risk to consumer health because it is a visible deviation. Should any customer still identify any units in their inventory, please contact the company to arrange for the collection of the product by e-mail sac2@laborimport.com.br or sac@laborimport.com.br
  • Reason
    According to the report of analysis nº 2384.00 / 2014, issued by the adolfo lutz institute, the safety jet 5ml safety syringe product, date of manufacture 01/2010, val 01/2015, lot 100120, was considered unsatisfactory in the aspect test .
  • Action
    The Sanitary Vigilance of the Municipality of São Paulo determined the interdiction and collection, by means of publication in the Official Gazette of the City of São Paulo on 09/23/2014 page 57, COVISA Communiqué No. 70/2014.

Device

5mL Safety Jet Safety Syringe, lot 100120 - registration no. 10369460041

Manufacturer

Labor Import; Anhui Tiankang Medical Products
  • Source
    ANVSANVISA