Events

Retiro De Equipo (Recall) de Device Recall CoopeSurigcal

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 CooperSurgical, 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
    70368
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1397-2015
  • Fecha de inicio del evento
    2013-05-01
  • Fecha de publicación del evento
    2015-04-07
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-06-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=133340
  • 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, disposable - Product Code IMD
  • Causa
    Trans warmer infant and transport mattress not labeled with exp.Date may not meet specification.
  • Acción
    CooperSurgical sent a formal recall notification letter dated April 4, 2015 to all affected customers. The letter identified the product problem and the action needed to be taken by the customer. CooperSurgical notified consignees affected by this recall via Fedex with confirmed delivery receipt. The letter identified the affected product and detailed the necessary actions to be taken by customers who carried the affected lots in their inventory. CooperSurigcal will replace any of the affected products that customers had on hand. CooperSurgical provided further instruction on the disposition of the product at the time of replacement. Contact CooperSurgical at 203 601 5200 Ext. 3100 if you have questions. Previously CooperSurgical notified consignees affected by this recall on 5/1/13.

Device

Device Recall CoopeSurigcal
  • Modelo / Serial
    Product with no lot/ expiration date on the product label
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide - in the countries of:ARGENTINA, AUSTRALIA,BAHRAIN, ,BERMUDA,CANADA,COLOMBIA ,ENGLAND, GERMANY,HUNGARY,INDONESIA, KUWAIT,LATVIA,LIBYA,MALAYSIA MEXICO,NEW ZEALAND,SAUDI ARABIA. TURKEY, UNITED ARAB EMIRATES
  • Descripción del producto
    CooperSurgical TransWarmer Infant Transport Mattress with WarmGel || P/N 20421 || Private label: || NovaPlus TransWarmer Infant Heat Therapy Mattress with || WarmGel. P/N V6390 || Provides warmth during transport of infant within the hospital || or between hospitals
  • Manufacturer
    CooperSurgical, Inc.

Manufacturer

CooperSurgical, Inc.
  • Dirección del fabricante
    CooperSurgical, Inc., 75 Corporate Dr, Trumbull CT 06611-1350
  • Empresa matriz del fabricante (2017)
    The Cooper Companies, Inc.
  • Source
    USFDA