Events

Alerta De Seguridad para KIMBERLY-CLARK STERILE SURGICAL CLOTHING MODEL: EXTRA GRAND ULTRA-REINFORCED APRON. Registro Anvisa n ° 80357219002. Affected lots: all lot numbers starting with: AH9284 *** a AH9356 ***; AH0007 *** a AH0356 ***; AH1008 *** to AH1364 ***; AH2006 *** to AH2146 ***.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Kimberly-Clark Brasil Indústria e Comercial de Produtos de Higiene Ltda..

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    1198
  • Fecha
    2012-11-12
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Check for additional information in the Kimberly-Clark Customer Letter document. The document is available at http://portal.anvisa.gov.br/wps/wcm/connect/496126804d6f9bcdbea8ffc116238c3b/Carta_ao_Cliente_1198.pdf?MOD=AJPERES. The Technovigilance Unit is following up on this case.
  • Causa
    Primary packaging of the product may be open, which compromises its sterility.
  • Acción
    The product in question is being collected by the registration holder. If you have any affected product, segregate it (identify it appropriately to avoid inadvertent use), and contact the company to report the fact through the Product Field Action Response Form. The form and the contact phone number of the company are available in the Letter to Customers document.

Device

KIMBERLY-CLARK STERILE SURGICAL CLOTHING MODEL: EXTRA GRAND ULTRA-REINFORCED APRON. Registro Anvi...

Manufacturer

Kimberly-Clark Brasil Indústria e Comercial de Produtos de Higiene Ltda.