Events

Safety Alert for SurePath Preservative Family, SurePath GYN Preservative Vial Kit 500, registration number 10033430537, risk class I, multiple lots (SEE ANNEX, link. -Anyxo + 1- + List + of + distribution + products + under + risk + in + Brasil.pdf? MOD = AJPERES

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Becton Dickinson Cirúrgicas Ltda.; TriPath Imaging, Inc..

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
    1839
  • Date
    2016-03-16
  • 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
  • Reason
    From customer reports, becton dickinson surgical ltda identified a fissure in the vial cap collection and transport of gynecological samples in a part of a few specific batches. the fissure was identified by customers before and / or after collection.
  • Action
    Action code 18_Fev16. Sending communication letter to clients.

Device

SurePath Preservative Family, SurePath GYN Preservative Vial Kit 500, registration number 1003343...

Manufacturer

Becton Dickinson Cirúrgicas Ltda.; TriPath Imaging, Inc.