Events

Retiro De Equipo (Recall) de PACEMAKER 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
    21521
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2017-01-23
  • 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
    Medline industries received a product advisory notice from bd concerning their eclipse needle. bd has received reports of safety cover disengagement and needlestick injury (nsi) for the bd eclipse needle. based on the customer reports in some cases when the safety cover is pushed over the needle it disengages resulting in an exposed needle which can increase the risk of nsi. the bd eclipse needle is a component in several medline custom procedure packs. medline canada is therefore informing its customers of the bd advisory notice.

Device

PACEMAKER PACK
  • Modelo / Serial
    Model Catalog: DYNJ52472X (Lot serial: CONTACT MFG); Model Catalog: DYNJ46890X (Lot serial: CONTACT MFG); Model Catalog: DYNJ46856X (Lot serial: CONTACT MFG); Model Catalog: DYNJ46726X (Lot serial: CONTACT MFG); Model Catalog: DYNJ46729X (Lot serial: CONTACT MFG); Model Catalog: DYNJ46858X (Lot serial: CONTACT MFG); Model Catalog: DYNJ46877X (Lot serial: CONTACT MFG); Model Catalog: DYNJ46859X (Lot serial: CONTACT MFG); Model Catalog: DYNJ46745X (Lot serial: CONTACT MFG); Model Catalog: DYNJ48513X (Lot serial: CONTACT MFG); Model Catalog: DYNJ900660X (Lot serial: CONTACT MFG); Model Catalog: DYNJ46835X (Lot serial: CONTACT MFG); Model Catalog: DYNJ46860X (Lot serial: CONTACT MFG); Model Catalog: DYNJ41876X (Lot serial: CONTACT MFG); Model Catalog: DYNJ46736X (Lot serial: CONTACT MFG); Model Catalog: CDS982078X (Lot serial: CONTACT MFG); Model Catalog: DYNJ48536X (Lot serial: CONTACT MFG); Model Catalog: DYNJ37224X (Lot serial: CONTACT MFG); Model Catalog: DYNJ41910X (Lot serial: CONTACT MFG); Model Catalog:
  • Descripción del producto
    PACEMAKER PACK;TVT WCH-LF;SHOULDER RVHS-LF;VAG HYS ANT PST REPAIR TEGH-LF;C SECTION TEGH-LF;MINOR PROCEDURE RVHS-LF;BREAST BIOPSY WCH-LF;MAJOR LIMB RVHS-LF;PACEMAKER TEGH-LF;ENDONASAL DCR MSH-LF;TMJ MSH-LF;C SECTION SJHC-LF;MINOR LIMB RVHS-LF;ANGIOGRAM LF
  • Manufacturer
    MEDLINE CANADA CORPORATION

Manufacturer

MEDLINE CANADA CORPORATION