Events

Retiro De Equipo (Recall) de HLD Systems

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 Cenorin, LLC.

¿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
    68237
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1729-2014
  • Fecha de inicio del evento
    2014-04-24
  • Fecha de publicación del evento
    2014-06-06
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-06-30
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127201
  • 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
    Device, pasteurization, hot water - Product Code LDS
  • Causa
    Cenorin llc is voluntarily recalling hld systems model 610 washer/high level disinfector due to a potential risk of the system not injecting the proper amount of cleaning fluid during the wash cycle and not achieving the desired level of debris reduction.
  • Acción
    Cenorin sent a letter on April 24, 2014 informing their customers of the potential failure of the pump. This letter also explains the customer's option of upgrading their entire HLD System to the new cleaning fluid delivery system or to continue purchasing a six month PM kit that has a replacement pump added. Customers are instructed to complete and return an enclosed response form within 15 days and to email Jamie Wright at jwright@cenorin.com or call 800-426-1042, extension 224 for questions.

Device

HLD Systems
  • Modelo / Serial
    610601, 610603, 610703, 610704, 610705, 610707, 610708, 610802, 610803, 610804, 610901, 610903, 610904, 610905, 610902, 611001, 611002, 611004, 611102, 611103, 611201, 611202, 611203, 610902L, 611204.  First two digits (61)  refer to model number 610 for the HLD system Second two digits - two digit year of manufacture Last two digits  sequentially numbered as they receive orders.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distribution USA Nationwide
  • Descripción del producto
    HLD Systems Model 610 Washer/High Level Disinfector. || Maximum weight of the Model 610 when filled with water is approximately 450 pounds. The dimensions of the system are: Width: 26.5" (67 cm); Depth: 33" (83 cm); Height: 46.5" (118 cm) to top of control panel; 64" (162.6 cm)- height clearance with lid open. || Product Usage: Usage: || This device washes reusable medical devices and disinfects them with high temperature hot water (pasteurization). The devices are washed with a cleaning solution (containing NaClO (sodium hypochlorite), surfactants, and detergents) to aid in the removal of debris and visible stains. Next, the medical devices and rinsed two times with water. The final, disinfection step uses only hot water at 160 F ¿ 2 F for 30 minutes.
  • Manufacturer
    Cenorin, LLC

Manufacturer

Cenorin, LLC
  • Dirección del fabricante
    Cenorin, LLC, 6324 S 199th Pl Ste 107, Kent WA 98032-2135
  • Empresa matriz del fabricante (2017)
    Cenorin L.L.C.
  • Source
    USFDA