Events

Safety Alert for Trade name: BLOOD COLLECTION PACKAGING CPDA-1 Technical name: BLOOD COLLECTION PACKAGE ANVISA registration number: 10154450076 Hazard class: III Model affected: COMPOFLEX 1F CPDA-1 Serial numbers affected: 71IM03AC00; 71IM04AB00; 71KH16AD00

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
    2253
  • Date
    2017-03-29
  • 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
    If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link
  • Reason
    The company received a report from a distributor, where it was informed about the occurrence of molded packaging labels of the product compoflex 1f cpda-1, lots: 71kh16ad00, 71kl19aa00 and 71kh17ac00. the company identified fungal growth on the label on the primary packaging of the product. after internal investigations, it was possible to conclude that the residual steam from the sterilization process combined with the paper label of this package was the cause of such a deviation. it was also verified that the sterility of the bags was not compromised and that it is only a damage on the label itself, and can be framed as a cosmetic deviation. although there is absolutely no indication that the sterility of the bags is compromised, fresenius hemocare has decided, as a precautionary measure, to collect these batches of the product.
  • Action
    Field Action Code 01-2017 triggered under the responsibility of the company FRESENIUS HEMOCARE BRASIL LTDA. Company will collect.

Device

Trade name: BLOOD COLLECTION PACKAGING CPDA-1 Technical name: BLOOD COLLECTION PACKAGE ANVISA reg...

Manufacturer

FRESENIUS HEMOCARE BRASIL LTDA; FRESENIUS HEMOCARE BRASIL LTDA