Events

Alerta De Seguridad para Strykeflow Suction Irrigator II Irrigators. Parts No. 250-070-500; Lots Nos .: 00065812 and 0065832

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Stryker Endoscopy Div Stryker Corp.

¿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
    240
  • Fecha
    2000-12-22
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Causa
    The primary blister packaging of the mentioned units may have cracks that may compromise the sterility of the product. the manufacturer initiated a telephone recall on june 28, 2000 and by mail dated august 25, 2000.
  • Acción
    Make sure that you have received the Medical Equipment Removal Notification correspondence dated August 25, 2000 and the Stryker Endoscopy Knowledge Receipt. Identify and isolate any affected product from your inventory. Return any affected product with return authorization, at no additional cost, to Stryker Endoscopy by mail at the above address. Contact your local representative or directly with the Stryker Endoscopy Customer Service Center by phone to receive a return authorization. Stryker Endoscopy states that upon receipt of the Receipt of Knowledge, it will automatically begin shipping the replacement product. Sign and complete the Knowledge Receipt and send it to Stryker Endoscopy by mail at the above address or by fax at 1 (408) 567-2505. For more information, contact your local representative or directly with Judy Toste, Stryker Endoscopy, by mail at the above address or fax 1 (408) 567-2505

Device

Strykeflow Suction Irrigator II Irrigators. Parts No. 250-070-500; Lots Nos .: 00065812 and 0065832

Manufacturer

Stryker Endoscopy Div Stryker Corp
  • Source
    ANVSANVISA