Events

Safety Alert for BLOOD COLLECTION BAG CPDA-1, Registration no. 10154450085 - lot: 71HL07AA00-04

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by 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
    1814
  • Date
    2016-01-26
  • 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
    0
  • Reason
    According to the single sample tax analysis report no. 115.105980, issued by the central laboratory of public health professor gonçalo moniz of the health secretariat of the state of bahia, the product bag for collection of blood cpda1, brand fresenius kabi, validity 10 / 2016, lot 71hl07aa00-04 was considered unsatisfactory in the appearance assay (presence of foreign body).
  • Action
    The company is collecting the product batch.

Device

BLOOD COLLECTION BAG CPDA-1, Registration no. 10154450085 - lot: 71HL07AA00-04

Manufacturer

Fresenius Hemocare Brasil Ltda.