Events

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

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Baxter Hospitalar Ltda.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    1159
  • Date
    2012-08-03
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    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.
  • Cause
    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