Events

Safety Alert for Disposable Hypodermic Syringe Safety 3ml, lot 101208 - registration # 10369460028

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Labor Import; Shandong Weigao Group Medical Polymer Co..

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
    1579
  • Date
    2015-05-15
  • 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 diversion verified was punctual, there being no risks to the health of the consumer as a visible deviation. If any customer still identifies any units in their inventory, please contact the company to arrange the collection of the product through the e-mail quality@laborimport.com.br
  • Reason
    According to the report of analysis nº 277.00 / 2015, issued by the instituto adolfo lutz, the product disposable hypodermic safety syringe 3ml, safety jet brand, date of manufacture 12/2010, val. 12/2015, lot 101208, was considered unsatisfactory in the aspect assay.
  • 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 of 04/11/2015, page 53, COVISA Communiqué Nº. 018/2015

Device

Disposable Hypodermic Syringe Safety 3ml, lot 101208 - registration # 10369460028

Manufacturer

Labor Import; Shandong Weigao Group Medical Polymer Co.
  • Source
    ANVSANVISA