Events

Safety Alert for Trade Name: BAG FOR BLOOD COLLECTION CPDA-1 /// Technical Name: BLOOD BAG /// ANVISA Registration Number: 10154450085 /// Risk Class: III - High Risk /// Model: Triple Bag with Plasticizers DEHP and TOTM - Composampler /// Serial numbers affected: 71KA18AA00.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by FRESENIUS HEMOCARE BRASIL LTDA.; FRESENIUS HEMOCARE BRASIL 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
    2003
  • Date
    2016-07-15
  • 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 product must be segregated and returned to FRESENIUS HEMOCARE BRASIL LTDA
  • Reason
    The company received an account from a blood bank about some medical complications related to the transfusion procedure with a patient.
  • Action
    Field Action Code RA 03-2016 triggered under the responsibility of the company FRESENIUS HEMOCARE BRASIL LTDA. Company is performing product recall.

Device

Trade Name: BAG FOR BLOOD COLLECTION CPDA-1 /// Technical Name: BLOOD BAG /// ANVISA Registration...

Manufacturer

FRESENIUS HEMOCARE BRASIL LTDA.; FRESENIUS HEMOCARE BRASIL LTDA.