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
    27968
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2017-01-17
  • País del evento
  • 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
    Medline industries received a recall notice from medtronic concerning the covidien devon light glove. the light glove may split upon application to the devon light handle adapter. the light glove is a component in several medline custom or procedure packs.

Device

  • Modelo / Serial
    Model Catalog: DYNJ33026X (Lot serial: CONTACT MFG); Model Catalog: DYNJ40048X (Lot serial: CONTACT MFG); Model Catalog: DYNJ41960X (Lot serial: CONTACT MFG); Model Catalog: DYNJ46813X (Lot serial: CONTACT MFG); Model Catalog: DYNJ46796X (Lot serial: CONTACT MFG); Model Catalog: DYNJ46801X (Lot serial: CONTACT MFG); Model Catalog: DYNJ50394X (Lot serial: CONTACT MFG); Model Catalog: DYNJS0910 (Lot serial: CONTACT MFG); Model Catalog: DYNJ48194X (Lot serial: CONTACT MFG); Model Catalog: DYNJ46791X (Lot serial: CONTACT MFG); Model Catalog: DYNJ46802X (Lot serial: CONTACT MFG); Model Catalog: DYNJ46792X (Lot serial: CONTACT MFG); Model Catalog: DYNJ46810X (Lot serial: CONTACT MFG); Model Catalog: DYNJ41945X (Lot serial: CONTACT MFG); Model Catalog: DYNJ46799X (Lot serial: CONTACT MFG); Model Catalog: DYNJ41952X (Lot serial: CONTACT MFG); Model Catalog: DYNJ46798X (Lot serial: CONTACT MFG); Model Catalog: DYNJ41668X (Lot serial: CONTACT MFG); Model Catalog: DYNJ41679X (Lot serial: CONTACT MFG); Model Catalog: DY
  • Descripción del producto
    OPEN HEART PACK;CABG PACK;UROLOGY MAJOR PACK LF;MINOR BASIC LH-LF;DHS VERSAFIX LH-LF;VAG HYSTERECTOMY LH-LF;EVAR PACK;LAPAROSCOPY TRAY;ROBOTICS PACK WRM-LF;ADULT HERNIA LH-LF;TUBAL LIGATION LH-LF;PERCUTANEOUS NEPHRO LH-LF;TVT KIT LAKERIDGE LH-LF;BREAST PA
  • Manufacturer

Manufacturer