Events

Retiro De Equipo (Recall) de KOOL-KIT NEONATE

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por CINCINNATI SUB-ZERO PRODUCTS.

¿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
    75528
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2014-10-31
  • 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
    Cincinnati sub-zero products inc. (csz) has initiated a correction on this medical device due to the omission of the probe ifu from the kool-kit neonate. the kool-kit neonate has been designed such that 1 of the individually packaged cat #491b probes is required for each tray. since the probes are received from their manufacturer in cartons containing 20 probes and 1 ifu 1 carton of probes will make 20 kool-kit neonate trays. the probe ifu has not been used during assembly of the kool-kit neonate trays since the product was first released for sale on 3/27/2009. however since the probe pouches are labeled with a 3 year shelf life this correction only applies to kool-kit neonates manufactured within the last 3 years. the probe ifu includes additional information that is not included within the labeling provided to the customer by csz.

Device

KOOL-KIT NEONATE
  • Modelo / Serial
    Model Catalog: 950 (Lot serial: >10 NUMBERS CONTACT MFG)
  • Descripción del producto
    KOOL-KIT NEONATE
  • Manufacturer
    CINCINNATI SUB-ZERO PRODUCTS

Manufacturer

CINCINNATI SUB-ZERO PRODUCTS
  • Dirección del fabricante
    CINCINNATI
  • Empresa matriz del fabricante (2017)
    Gentherm, Inc.
  • Source
    HC