Events

Retiro De Equipo (Recall) de DISCPAC TIP CAPS

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
    44673
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2014-12-24
  • 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
    During a label review it was identified that the single and case label templates for discpac tip caps did not include the latex symbol. discpacs were shipped with a missing latex symbol on both single and case label artwork. the ifu correctly identifies the latex content. the heat shrink tape used on the discpac package is the only component that contains latex. the tape does not come into direct contact with the tip caps but must be peeled away and removed to access the self-righting tip caps.

Device

DISCPAC TIP CAPS
  • Modelo / Serial
    Model Catalog: H938672025 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: H938678100 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: H938679025 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: H938679100 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: H93868100 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: H938690025 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: H93869025 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: H93869100 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: H938677100 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: H938677025 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: H938676100 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: H938676025 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: H938674100 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: H938674025 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: H938673100 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: H938673025 (Lot seria
  • Descripción del producto
    DISCPAC TIP CAPS
  • Manufacturer
    BAXTER CORPORATION

Manufacturer

BAXTER CORPORATION