Events

Retiro De Equipo (Recall) de JACKSON-PRATT SILICONE FLAT DRAINS W/WO TROCARS

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
    52558
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2017-04-27
  • 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 has become aware of a potential breach of sterility in the packaging of certain jackson-pratt perforated and hemaduct wound drainage systems. in a small percentage of product (approximately 1.6%) the inner packaging (polybag) is caught in the seal area of the outer tyvek pouch potentially compromising the sterility of the package contents. while sterility is only impacted if the polybag fully breaches the seal (approximately 0.23% of product) as a precautionary measure cardinal health is taking this action to ensure that product is not used if any portion of the polybag is caught in the seal area. use of impacted products could result in an increased risk of infection.

Device

JACKSON-PRATT SILICONE FLAT DRAINS W/WO TROCARS
  • Modelo / Serial
    Model Catalog: SU130-1309 (Lot serial: > 100 NUMBERS CONTACT MFG); Model Catalog: SU130-1308 (Lot serial: > 100 NUMBERS CONTACT MFG); Model Catalog: JP-HUF100 (Lot serial: > 100 NUMBERS CONTACT MFG); Model Catalog: SU130-1310 (Lot serial: > 100 NUMBERS CONTACT MFG); Model Catalog: SU130-1410 (Lot serial: > 100 NUMBERS CONTACT MFG); Model Catalog: SU130-1411 (Lot serial: > 100 NUMBERS CONTACT MFG); Model Catalog: SU130-1311 (Lot serial: > 100 NUMBERS CONTACT MFG); Model Catalog: SU130-1323 (Lot serial: > 100 NUMBERS CONTACT MFG); Model Catalog: SU130-1321 (Lot serial: > 100 NUMBERS CONTACT MFG); Model Catalog: SU130-1320 (Lot serial: > 100 NUMBERS CONTACT MFG); Model Catalog: SU130-0323 (Lot serial: > 100 NUMBERS CONTACT MFG); Model Catalog: SU130-0321 (Lot serial: > 100 NUMBERS CONTACT MFG); Model Catalog: SU130-0521 (Lot serial: > 100 NUMBERS CONTACT MFG); Model Catalog: JP-HUR190 (Lot serial: > 100 NUMBERS CONTACT MFG); Model Catalog: JP-HUR151 (Lot serial: > 100 NUMBERS CONTACT MFG); Model Catalog: JP-HUR
  • Descripción del producto
    JACKSON-PRATT SILICONE FLAT DRAINS W/WO TROCARS;JACKSON-PRATT SILICONE ROUND DRAINS W/WO TROCARS;JACKSON-PRATT PVC ROUND DRAINS WITH ATTACHED TROCAR
  • Manufacturer
    CARDINAL HEALTH CANADA INC.

Manufacturer

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