Events

Safety Alert for COSEAL 4ML and 8ML. Anvisa Registry n ° 80145240375. Affected lots: HA111018 and HA111021.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Baxter Hospitalar 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
    1159
  • Date
    2012-08-03
  • 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
    According to the company, during waiting for release at customs the product was exposed to temperatures higher than the maximum temperature validated for storage, which may compromise its stability. The field action was initiated on 05/31/2012 by the company and, according to information presented by Baxter to this UTVIG, the end of the product collection is scheduled for October 31, 2012. #### Update (05 / 09/2012): the company sent a Monitoring Report stating that after 60 days of commencement of the communication to customers, of the 56 units sold were consumed 40 units by the customers and 16 units were collected by the company. The company's next action is the destruction of the products collected. #### Update (11/29/2012): According to the field action report presented by the company, the action was closed on 10/31/2012. Fourteen units of the product Coseal 4ml and 2 units of the product Coseal 8ml were collected (71 and 30 units in Brazil, respectively). According to Baxter, all affected customers responded to the company's statement and the units collected were destroyed on 09/05/2012.
  • Reason
    Possibility of loss of effectiveness.
  • Action
    The company has already started communicating the field action to its customers and the collection of the product is scheduled for the beginning of August 2012. Check in your inventory the existence of products affected by this field action and segregate the products located, identifying them to avoid inadvertent use. Follow the recommendations of Baxter Hospitalar Ltda regarding the return of affected products to the company.

Device

COSEAL 4ML and 8ML. Anvisa Registry n ° 80145240375. Affected lots: HA111018 and HA111021.

Manufacturer

Baxter Hospitalar Ltda
  • Source
    ANVSANVISA