Events

Retiro De Equipo (Recall) de SYNTRA DIALYZER 120

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por BAXTER CORPORATION.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    21917
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2002-09-12
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 recall data from the U.S. and Canada.
  • Notas adicionales en la data
  • Causa
    Manufacturer has received a small number of confirmed reports of saline and blood leaks from the header during priming of the dialyzer.

Device

SYNTRA DIALYZER 120
  • Modelo / Serial
    Model Catalog: R5M6243 (Lot serial: 4.); Model Catalog: R5M6246 (Lot serial: H02D26112 H02D21118 H02F2202); Model Catalog: R5M6243 (Lot serial: H02C20133 H02C20133A H02F110); Model Catalog: R5M6243 (Lot serial: 2C13112A H02C15083 H02C18152); Model Catalog: R5M6243 (Lot serial: 0102 H02B02018 H02C13112 H0); Model Catalog: R5M6243 (Lot serial: 5 H01L14048 H02A29138 H02A3); Model Catalog: R5M6243 (Lot serial: H01J13044 H01J15155 H01L1250); Model Catalog: R5M6243 (Lot serial: 3481 H01I27029 H01I29017A); Model Catalog: R5M6243 (Lot serial: H01G30068 H01H01075 H01H0203); Model Catalog: R5M6243 (Lot serial: 0040 H01E02129 H01G02067); Model Catalog: R5M6243 (Lot serial: 4 H01D09036 H01D10091 H01D3); Model Catalog: R5M6243 (Lot serial: h01c05093H01C26032 H01D0503); Model Catalog: R5M6243 (Lot serial: 2 H01H24077 H01H25025 H01I2); Model Catalog: R5M6243 (Lot serial: H02F17041 H02F18106 H02F1849); Model Catalog: R5M6246 (Lot serial: 02071 H02D07492 H02D22152); Model Catalog: R5M6246 (Lot serial: 64 H02C10506 H02C11561
  • Descripción del producto
    SYNTRA 120 DIALYZER
  • Manufacturer
    BAXTER CORPORATION

Manufacturer

BAXTER CORPORATION