Events

Retiro De Equipo (Recall) de InterPulse Handpiece Set With Bone Cleaning Tip and Suction Tube

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 Instruments 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
    57470
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0952-2011
  • Fecha de inicio del evento
    2010-10-04
  • Fecha de publicación del evento
    2011-01-25
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-06-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96299
  • 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
    Lavage, jet - Product Code FQH
  • Causa
    There is potential for a breach in sterility in the blister packaging. this can lead to the use of non-sterile product which, if contaminated, could lead to a patient infection.
  • Acción
    Stryker sent a Medical Device Recall Notification letter dated October 8, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to destroy and dispose of all affected product and to complete the business reply form and return to Stryker to receive replacement interpulse products at no charge. For questions regarding this recall call (269) 323-7700.

Device

InterPulse Handpiece Set With Bone Cleaning Tip and Suction Tube
  • Modelo / Serial
    Part Number 0210-114-000E;  Lot Number 09364012; Expires 12/1/2011
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (including all 50 states) and the countries of Brazil, Canada, France, Germany, Japan, Netherlands, South Africa, South Korea, Spain, Sweden, Switzerland and the UK.
  • Descripción del producto
    The Stryker InterPulse system is a single patient use, sterile, disposable, pulsed lavage device. The system consists of an irrigation handpiece, irrigation tubing, irrigation tips, suction tips, suction tubing, and splash shields. || The components of the InterPulse Irrigation System are used for wound debridement, soft tissue debridement and cleansing of medical, clinical and surgical sites. This includes cleansing of bone in surgical procedures, hydrodebridement of chronic wounds, debridement of loose skin from burns and cleansing of trauma wounds.
  • Manufacturer
    Stryker Instruments Division of Stryker Corporation

Manufacturer

Stryker Instruments Division of Stryker Corporation
  • Dirección del fabricante
    Stryker Instruments Division of Stryker Corporation, 4100 East Milham Ave., Kalamazoo MI 49001
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    USFDA