Retiro De Equipo (Recall) de ANGIO RADIOGRAPH

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
    15306
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2017-06-15
  • 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 was informed of a recall of the bd needle 22g 1.5" safetyglide product code 301701. this needle is a component in several medline custom packs. bd issued the recall due to the presence of loose polypropylene foreign matter. this foreign matter has been identified as product hub material.

Device

  • Modelo / Serial
    Model Catalog: DYNJ33248X (Lot serial: CONTACT MFG); Model Catalog: DYNJ46912X (Lot serial: CONTACT MFG); Model Catalog: DYNJ41909X (Lot serial: CONTACT MFG); Model Catalog: DYNJ41699X (Lot serial: CONTACT MFG); Model Catalog: DYNJ48535X (Lot serial: CONTACT MFG); Model Catalog: DYNJ41790X (Lot serial: CONTACT MFG); Model Catalog: DYNJ48528X (Lot serial: CONTACT MFG); Model Catalog: DYNJ50501X (Lot serial: CONTACT MFG); Model Catalog: DYNJ41704X (Lot serial: CONTACT MFG); Model Catalog: DYNJ54021X (Lot serial: CONTACT MFG); Model Catalog: DYNJ41799X (Lot serial: CONTACT MFG); Model Catalog: DYNJ41694X (Lot serial: CONTACT MFG); Model Catalog: DYNJ41712X (Lot serial: CONTACT MFG); Model Catalog: DYNJ900657X (Lot serial: CONTACT MFG); Model Catalog: DYNJ900656X (Lot serial: CONTACT MFG); Model Catalog: DYNJ51582X (Lot serial: CONTACT MFG); Model Catalog: DYNJ41914X (Lot serial: CONTACT MFG); Model Catalog: DYNJ51653X (Lot serial: CONTACT MFG)
  • Descripción del producto
    ANGIO RADIOGRAPH;HEART BIOPSY PACK TWH-LF;HAND FINGERS PACK LF;LAPAROSCOPIC CHOLE PACK;VAGINAL HYSTERECTOMY MSH-LF;GYNE MINOR LAPAROSCOPY GRH LF;LAVH MSH-LF;PLASTIC IMPLANT PACK HSN;PACEMAKER PACK LF;BREAST PACK;GENERAL MINOR ABDOMINAL GRH LF;VAG RECTAL P
  • Manufacturer

Manufacturer