Events

Retiro De Equipo (Recall) de Steris Quick Connects (QC) QFC1728 and QFC1729

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Steris Corporation Hopkins Facility.

¿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
    44810
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0101-2008
  • Fecha de inicio del evento
    2007-09-12
  • Fecha de publicación del evento
    2007-10-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-09-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=64407
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Steris Quick Connects - Product Code MED
  • Causa
    Loose or missing adaptor: the center insert of the adaptor #6 restrictor could become loose and/or come out of the adaptor's housing. the absence of adaptor #6's center insert may affect the sterilization process of the attached endoscope.
  • Acción
    STERIS has contacted affected direct accounts by phone to notify direct accounts of the recall. On 9/28/2007, STERIS will mail a recall notification to all affected direct accounts via certified mail. The notification informs direct accounts that STERIS representatives will be visiting direct accounts to retrieve affected products and provide replacements. Where direct accounts further distribute, STERIS representatives will inform the direct accounts to contact their sub-accounts and facilitate exchange of affected product for replacement product. Replacement product will be available beginning November 1, 2007.

Device

Steris Quick Connects (QC) QFC1728 and QFC1729
  • Modelo / Serial
    C041782, C041793, 3072287, C041514, C041512, C041508, C041513, C041515, 3072303, 3290749, 3338126, C041781, C041794, 3072246, C041506, C041509, C041510, C041511, 3072261, 3290723, 3318292, 3338100, 3352374, 3542412, 3643871, 3546157, 3656121, 3893160, 3890027, 3748456, 3930062, 3978731, 3342342, 3352390, 3575941, 3643897, 3668357, 3895661, 3900198
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide: United States, Australia, Bahrain, Canada, Germany, Great Britain, Hungary, Italy, Qatar, and Spain
  • Descripción del producto
    Steris QFC1728 and QFC1729 Quick Connects;(used to connect gastrointestinal endoscopes to processing trays) The malfunctioning piece of the quick connect component is adaptor #6, STERIS part number 201158. Adaptor #6 attaches to the suction port of the endoscope.
  • Manufacturer
    Steris Corporation Hopkins Facility

Manufacturer

Steris Corporation Hopkins Facility
  • Dirección del fabricante
    Steris Corporation Hopkins Facility, 6515 Hopkins Rd, Mentor OH 44060-4307
  • Empresa matriz del fabricante (2017)
    Steris Plc
  • Source
    USFDA