Events

Retiro De Equipo (Recall) de Device Recall CT99 Cold Therapy Pad

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 Cincinnati Sub-Zero Products 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
    70207
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1129-2015
  • Fecha de inicio del evento
    2015-01-07
  • Fecha de publicación del evento
    2015-02-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-06-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132502
  • 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
    Pack, hot or cold, water circulating - Product Code ILO
  • Causa
    Seals in the water path of the ct-99 cold therapy pad may separate during use, which could lead to a water leak.
  • Acción
    Cincinnati Sub-Zero sent an Urgent Medical Device Recall Field Action Notice dated January 7, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately cease use and/or further distribution of the affected product. Customers were instructed to obtain a Return Material Authorization Number and return the pad(s) for exchange. Customers with questions were instructed to call 1-800-989-7373 or 513-772-8810. Customers were also asked to commplete and return the enclosed Response Form as soon as possible by fax to (513)772-9119 to acknowledge receipt of the notification and to inform CSZ that they have performed the requested actions. For questions regarding this recall call 513-772-8810, ext 6816

Device

Device Recall CT99 Cold Therapy Pad
  • Modelo / Serial
    Model: Catalog #CT -99 Part number: 50137 Lot number(s): 13380, 13390 and 13418.
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including FL, IL, TN, GA, VA, MO, NM, WI, MI, NC, IN, OH, MA, CA, WA, PA, KY, MD, HI, and AL.
  • Descripción del producto
    Cold Therapy Pad - cold water circulating pad, one unit per package. || The pads are used to provide a patient with local cold therapy by circulating chilled water through the pad that has been positioned on the patient.
  • Manufacturer
    Cincinnati Sub-Zero Products Inc

Manufacturer

Cincinnati Sub-Zero Products Inc
  • Dirección del fabricante
    Cincinnati Sub-Zero Products Inc, 12011 Mosteller Rd, Cincinnati OH 45241-1528
  • Empresa matriz del fabricante (2017)
    Gentherm, Inc.
  • Source
    USFDA