Events

Safety Alert for Product name: Leukocyte removal filter for laboratory use Technical Name: Leukocyte Removal Filter (Laboratory) ANVISA Registration Number: 10154450112 Hazard Class: III Model Affected: COMPOSTOP Serial numbers affected: 71KE05GA00, 71KE10GA00 , 71KE25GC00 and 71KG07GA00

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
    2318
  • Date
    2017-06-23
  • 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
    Disregard the phrase "Special lot - exclusive use for carrying out analysis (Prohibited for human use)" contained on the label. The product can be used normally.
  • Reason
    The company has identified that the product has been labeled with an improper label. this label is used in internal lots for validation purposes and therefore contains the phrase "special lot - exclusive use for analysis (prohibited for human use)", however, due to an operational failure, some commercial lots were labeled with this label. it should be emphasized that the products are fully compliant and ready to be marketed and can be used normally. after internal investigations, it was possible to show that this deviation was due to an operational failure during the label layout review process. all corrective and preventive actions have already been duly implemented by the company, in order to remedy such deviation.
  • Action
    Field Action Code 02-2017 triggered under the responsibility of the company Fresenius Hemocare Brasil LTDA. Company will report that there is an improper phrase on the product label.

Device

Product name: Leukocyte removal filter for laboratory use Technical Name: Leukocyte Removal Filte...

Manufacturer

Fresenius Hemocare Brasil LTDA; Fresenius Hemocare Brasil LTDA