Events

Safety Alert for SOLIDOR HYPODERIC NEEDLE, Hazard Class II, Model: 40 x 1.2 (18G x 1 1/2 "), Registration: 10237580042. Batch: BE30H / 14D01.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by LAMEDID COMERCIAL E SERVIÇOS LTDA; Anhui Easyway Medical Supplies Co., Ltd..

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
    1516
  • Date
    2014-12-17
  • 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
    At the moment, no technical complaint regarding this model / batch has been registered that could offer any risk to its users. This was a field action triggered based on the information received from COVISA (SP), published in the DOC of 11/27/2014 - page 81. #### Update of the field action: UPDATED ON 10/16/2017, the company presented the report of completion of the field action proving the destination of non-compliant products.
  • Reason
    Identified the presence of a foreign body (hair) attached to the sealing of the packaging of this needle, resulting from unsatisfactory aspect analysis.
  • Action
    The company that holds the register will collect the needles. The company advises customers to immediately discontinue the use of the product from the batch mentioned, segregating them and identifying them so that they are not inadvertently used. They will be collected and destroyed. (LETTER TO THE CUSTOMER IN ANNEX)

Device

SOLIDOR HYPODERIC NEEDLE, Hazard Class II, Model: 40 x 1.2 (18G x 1 1/2 "), Registration: 1023758...

Manufacturer

LAMEDID COMERCIAL E SERVIÇOS LTDA; Anhui Easyway Medical Supplies Co., Ltd.
  • Source
    ANVSANVISA