Events

Retiro De Equipo (Recall) de SIRUS SURGICAL GOWN

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
    144477
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2017-06-07
  • 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 was informed by the vendor that one lot of sirus surgical gown product code dynjp2229s was manufactured with inconsistent sealing of the breathable sleeve seam material. the gown is manufactured using a spunbond-meltblown-spunbond (sms} base material which is used for the body of the gown. the chest area/critical zone is reinforced with a polyethylene coated spunbond polypropylene material. the arms are manufactured using a breathable film material which is stitched to the body. the gown is labeled as an aami level 4 gown. the sleeve seam of the breathable material was found to have inconsistent sealing which has the potential to allow fluid to flow pass through the protective seam. this defect was detected during laboratory testing per astm f 1671 - standard test method for resistance of materials used in protective clothing to penetration by blood-borne pathogens using phi-x174 bacteriophage penetration where failures were seen at the sleeve seam. no complaints or mdr's have been filed for open seams or for fluid passing through the seams onto the user.

Device

SIRUS SURGICAL GOWN
  • Modelo / Serial
    Model Catalog: DYNJP2229S (Lot serial: 45016070513PH)
  • Descripción del producto
    SIRUS SURGICAL GOWN
  • Manufacturer
    MEDLINE CANADA CORPORATION

Manufacturer

MEDLINE CANADA CORPORATION