Events

Safety Alert for (S): IAB-S730C ## Batch (s) / Serial Number (s): IAB-S730C ## STR: ) 18F14A0041 18F14G0077 18F14C0003 18F14H0011 18F14C0006 18F15B0023 18F14C0021 18F15C0001 18F14C0026 18F15C0008 18F14C0027 18F15C0026 18F14C0028 18F14E0039 18F14E0055 18F14E0058 18F14F0038 18F14C0026 #

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by GABMED PRODUTOS ESPECÍFICOS LTDA; ARROW INTERNATIONAL 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
    1851
  • Date
    2016-04-04
  • 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 affected products must be segregated. ## The company ISOMEDICAL COMERCIAL - CNPJ: 00.757.668 / 0001-88 Address: R: GUILHOBEL, 41 VILA MONTE ALEGRE. SÃO PAULO-SP is coordinating the Field Action, since it imported the product with the authorization of the registration holder.
  • Reason
    Bleeding with significant blood loss during the procedure if there is separation between the valve and the body of the product sheath during use.
  • Action
    The company is performing the collection of the affected products for later return to the foreign manufacturer. LETTER TO THE CUSTOMERS IN ANNEX. Field Action Code: 001/2016

Device

(S): IAB-S730C ## Batch (s) / Serial Number (s): IAB-S730C ## STR: ) 18F14A0041 18F14G0077 18F14C...

Manufacturer

GABMED PRODUTOS ESPECÍFICOS LTDA; ARROW INTERNATIONAL INC.
  • Source
    ANVSANVISA