Events

Retiro De Equipo (Recall) de Device Recall STRYKER CASSETTE PUMP, AHTO Tube Set

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 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
    78668
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0836-2018
  • Fecha de inicio del evento
    2017-11-17
  • 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=162094
  • 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
    Apparatus, suction, operating-room, wall vacuum powered - Product Code GCX
  • Causa
    Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates.
  • Acción
    On about 11/17/2017 letters were sent by certified mail with tracking information to all domestic accounts and International Stryker sites were notified by email. Instructions include to inform individuals who need to be aware of the device recall, examine all stock areas and/or operating room storage for affected product quarantine and discontinue use of the recalled devices, complete the acknowledgement form, and if affected product is found contact Stryker customer service at 1-800-624-4422 (Option 3) or email endocustomersupport@stryker.com to arrange for product return.

Device

Device Recall STRYKER CASSETTE PUMP, AHTO Tube Set
  • Modelo / Serial
    a. Model 0250070600, UDI 07613327061499, Lot No. 17284FG2, 17291FG2, 17300FG2;  b. Model 0250070620, UDI 07613327061659, Lot No. 17275FG2, 17279FG2, 17280FG2, 17282FG2, 17283FG2, 17284FG2, 17285FG2, 17286FG2, 17289FG2, 17291FG2, 17292FG2, 17293FG2, 17297FG2, 17298FG2, 17299FG2;
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed domestically to . Distributed internationally to Australia and Mexico.
  • Descripción del producto
    STRYKER CASSETTE PUMP, AHTO Tube Set, labeled sterile. Includes the following: || a. Stryker AHTO Tube Set Packaging (Model 0250070600); || b. Stryker AHTO Tube Set with Tip Packaging (Model 0250070620);
  • Manufacturer
    Stryker Corporation

Manufacturer

Stryker Corporation
  • Dirección del fabricante
    Stryker Corporation, 5900 Optical Ct, San Jose CA 95138-1400
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    USFDA