Events

Retiro De Equipo (Recall) de TRANSVERSE LAPAROTOMY PACKS

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por CARDINAL HEALTH CANADA INC..

¿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
    52123
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2018-03-06
  • 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
    Cardinal health presource kits were exposed to temperature variations during transportation which are outside the range of the supplier's approved labelling. as such these temperature excursions may have impacted the effectiveness of certain components within the kits.

Device

TRANSVERSE LAPAROTOMY PACKS
  • Modelo / Serial
    Model Catalog: SBA30TRNHJ (Lot serial: 467489); Model Catalog: SAN30CLSLR (Lot serial: 468870); Model Catalog: SBA30MNNLE (Lot serial: 469042); Model Catalog: SAN30CCSLH (Lot serial: 468563); Model Catalog: SLC30LCNLF (Lot serial: 468653); Model Catalog: SAN30CLCRE (Lot serial: 468870); Model Catalog: SAN30CCUA1 (Lot serial: 468870); Model Catalog: SAN30CCSLH (Lot serial: 468870); Model Catalog: SAN30CLSLR (Lot serial: 469135); Model Catalog: SAN30CLCRE (Lot serial: 469135); Model Catalog: SAN30CCUA1 (Lot serial: 469135); Model Catalog: SAN30CCSLH (Lot serial: 469135); Model Catalog: SAN30CLSLR (Lot serial: 468238); Model Catalog: SAN30CLCRE (Lot serial: 468238); Model Catalog: SAN30CCUA1 (Lot serial: 468238); Model Catalog: SAN30CCSLH (Lot serial: 468238); Model Catalog: SAN30CLSLR (Lot serial: 468563); Model Catalog: SAN30CLCRE (Lot serial: 468563); Model Catalog: SAN30CCUA1 (Lot serial: 468563); Model Catalog: SCV30EPUA1 (Lot serial: 467711); Model Catalog: SBA30LTNLE (Lot serial: 468401); Model Catalog:
  • Descripción del producto
    TRANSVERSE LAPAROTOMY PACKS;CARDIAC CATHETERIZATION PACKS;MINOR LAPAROTOMY PACKS;LAP CHOLE PACKS;EP PACK;MINOR LITHOTONY PACKS;MAXIMAL BARRIER;ENSEMBLE PACEMAKER;KNEE PACKS;C SECTION PACK;CATHETERIZATION PACK;MAJOR LAPAROTOMY PACKS;ENSEMBLE CORONARY
  • Manufacturer
    CARDINAL HEALTH CANADA INC.

Manufacturer

CARDINAL HEALTH CANADA INC.
  • Dirección del fabricante
    MISSISSAUGA
  • Empresa matriz del fabricante (2017)
    Cardinal Health
  • Source
    HC