Events

Retiro De Equipo (Recall) de OPEN HEART PACK

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por MEDLINE CANADA 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
    25828
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2015-04-30
  • 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
    These packs contain a light handle cover manufactured by medtronic (formerly covidien). the covidien devont light handle cover is a sterile plastic sheath that slides over the handle of the overhead surgical light. it allows a gloved surgeon or or nurse to grab the handle with sterile gloves to maintain sterility. medtronic has initiated a voluntary recall of the light handle cover due to potential defects that may compromise the integrity of the product. a copy of medtronic's recall letter is attached.

Device

OPEN HEART PACK
  • Modelo / Serial
    Model Catalog: DYNJ33026X (Lot serial: >10 numbers contact mfg); Model Catalog: DYNJ41666X (Lot serial: >10 numbers contact mfg); Model Catalog: DYNJ33288X (Lot serial: >10 numbers contact mfg); Model Catalog: DYNJ47601X (Lot serial: 14JB6768); Model Catalog: DYNJ46799X (Lot serial: 15MB6363); Model Catalog: DYNJ47601X (Lot serial: 14GB4580); Model Catalog: DYNJ46813X (Lot serial: 15CB7129); Model Catalog: DYNJ46813X (Lot serial: 14LB10457); Model Catalog: DYNJ46796X (Lot serial: 15BB7629); Model Catalog: DYNJ46801X (Lot serial: 15OB3443); Model Catalog: DYNJ46801X (Lot serial: 15NB1069); Model Catalog: DYNJ46801X (Lot serial: 14LB1053); Model Catalog: DYNJ40049X (Lot serial: >10 numbers contact mfg); Model Catalog: DYNJ41834X (Lot serial: 13TB1836); Model Catalog: DYNJ47601X (Lot serial: 14HB8722); Model Catalog: DYNJ41679X (Lot serial: >10 numbers contact mfg); Model Catalog: DYNJ41668X (Lot serial: 13IB1520); Model Catalog: DYNJ41668X (Lot serial: 13JB2275); Model Catalog: DYNJ41668X (Lot serial: 14MB0571
  • Descripción del producto
    Open Heart Pack
  • Manufacturer
    MEDLINE CANADA CORPORATION

Manufacturer

MEDLINE CANADA CORPORATION