Events

Safety Alert for GUIDE TO TEFLONATE ANGIOPLASTY 0.035 "X 150 CM JET BIOMETRIX, Model HR-3823. ANVISA Registration No. 10332200028. Lot under risk: I8119.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by BIOMETRIX LTD (ISRAEL).; EPTCA Medical Devices 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
    1335
  • Date
    2013-12-11
  • 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 information presented by EPTCA Ltda, packaging was evidenced without the heat seal, which exposes the product to the environment and, consequently, compromises its sterility.
  • Reason
    Possible absence of heat seal in the primary packaging of the product, leading to the loss of the guarantee of its sterilization.
  • Action
    The product is being collected by the registration holder in Brazil. Identify in your stock and in the stocks of your customers (in the case of distributors) products under risk, verifying the integrity of the packaging sealing of all units of the product in question. Once defective products have been identified, segregate them to avoid inadvertent use. Please contact the record holder or your distributors for return purposes.

Device

GUIDE TO TEFLONATE ANGIOPLASTY 0.035 "X 150 CM JET BIOMETRIX, Model HR-3823. ANVISA Registration ...

Manufacturer

BIOMETRIX LTD (ISRAEL).; EPTCA Medical Devices Ltda.
  • Source
    ANVSANVISA