Events

Safety Alert for HEM-O-LOK CLIPS (Reg. 80117580001); ENDOSCOPIC APPLICATOR AND HEM-O-LOK CLIPS (Reg. 80117580004); CLIPS DE TITÂNIO HORIZON (Reg. 80117580007). Products Affected: Lots produced until end of July 2008.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Weck Closures Systems.

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
    943
  • Date
    2008-10-08
  • 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
    The holder of the registration of the products in Brazil (Brasil Import Ltda.) Received from the manufacturer an alert reporting quality control failure in relation to some product packaging - the process of placing the staple cartridge in the blister caused damage in some packages, resulting in holes that compromise the sterility of the products. As a result of the problem, the registry holder, together with the authorized distributor of the product (TC Técnica Cirúrgica Ltda), decided to collect all lots of the products under risk marketed in Brazil. Brasil Import Ltda informed the Tecnovigilance Unit that it has already started sending letters of communication to its clients (see Attachment to Customers - http://www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2008/alerta_943_carta.pdf) .
  • Reason
    Possibility of holes in the packaging of the staples, which can compromise the sterility of the products.
  • Action
    The company that owns the product registrations in Brazil (Brasil Import Ltda.) Informed the Anvisa Tecnovigilance Unit (UTVIG / ANVISA) that it suspended the sale and is collecting all the batches of the mentioned products from the market (see Product Description field). The actions recommended to users and distributors of the products are as follows: (a) Check your stock and immediately stop the use / distribution of products at risk; (b) Segregate the products at risk, identifying them correctly to avoid inadvertent use; (c) Return the affected products to the distributor TC Técnica Cirúrgica Ltda (Rua Alberto Folloni 1040 - Bairro Ahú - CEP: 80540-000 - Curitiba / PR); (d) The Stock Status Report and Recognition Form for the aforementioned products must be sent to TC Técnica Cirúrgica Ltda through FAX (41) 3302-2133, even if the affected product is not found in stock.

Device

HEM-O-LOK CLIPS (Reg. 80117580001); ENDOSCOPIC APPLICATOR AND HEM-O-LOK CLIPS (Reg. 80117580004);...

Manufacturer

Weck Closures Systems
  • Source
    ANVSANVISA