Events

Retiro De Equipo (Recall) de Device Recall T/Pump

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 Stryker Medical Division of Stryker Corporation.

¿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
    79302
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-1013-2018
  • Fecha de inicio del evento
    2017-11-07
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161846
  • 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
    The t/pump operations manual and maintenance manual were incorrectly revised to add the sentence, temperature therapy can also be for heat conservation for normothermia maintenance to the indications for use statement.
  • Acción
    The following actions are included in the consignee letter: 1. Locate the operations (101515 rev D.0) and maintenance (101176 rev F.0) manuals that accompanied the units listed on the attached business reply form. 2. Find the corrected pages included in this letter and insert one into each affected manual at your location. 3. Complete the enclosed business reply form to acknowledge that you have received and understand this notification. 4. Return your completed business reply form by fax 269 488 8691 or email productfieldaction@stryker.com to Strykers regulatory department. 5. If you have loaned or sold any of the products listed in this letter, please forward a copy of this notice to the new users and advise us of their new location in the space provided on the business reply form. 6. If you have disposed of any of these units and they are no longer in use, please, advise us of their obsolescence by providing us with their serial number in the space provided on the business reply form.

Device

Device Recall T/Pump

Manufacturer

Stryker Medical Division of Stryker Corporation
  • Dirección del fabricante
    Stryker Medical Division of Stryker Corporation, 3800 E Centre Ave, Portage MI 49002-5826
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    USFDA