Events

Retiro De Equipo (Recall) de Device Recall CBC II Wound Drains

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 Div. 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
    70841
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1566-2015
  • Fecha de inicio del evento
    2015-03-26
  • Fecha de publicación del evento
    2015-05-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-12-31
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135090
  • 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, single patient use, portable, nonpowered - Product Code GCY
  • Causa
    Stryker instruments is voluntarily recalling the cbcii wound drains and ambulating bulb for a potential sterility breach in the packaging.
  • Acción
    An URGENT MEDICAL DEVICE NOTIFICATION letter was sent to all customers on 03/31/2015. The letter identified the affected product, the reason for the recall, the risk to health, and actions to be taken by the customer or user. All are asked to sign the Business Reply Form stating they have read the Notification and followed all instructions within. Customers were asked to immediately check all inventory and quarantine any affected product, return affected product to Stericycle for destruction using a return label provided by Stericycle. Upon receipt of affected product a credit will be issued to customer account.

Device

Device Recall CBC II Wound Drains
  • Modelo / Serial
    Part Number: 0215-019-000 and lot numbers: 10095012 10312012 11060012 11186012 11346012 12115012 12349012 13262012 10109012 10321012 11067012 11192012 11356012 12157012 13017012 13277012 10127012 10347012 11088012 11220012 12003012 12193012 13023012 13347012 10189012 10355012 11097012 11230012 12009012 12206012 13044012 14020012 10195012 11011012 11117012 11269012 12026012 12235012 13063012 14030012 10274012 11039012 11136012 11286012 12031012 12290012 13145012 14039012 10285012 11059012 11178012 11335012 12060012 12310012 13254012 14066012
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution. US nationwide, Australia, Great Britain, The Netherlands, Spain, Romania, Greece, Switzerland, South Africa, and Japan.
  • Descripción del producto
    1/4 in. Trocar with Single Drain || Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection from the sharp end of the trocar during handling. The double trocar wound drain has metal trocars on either side of the flexible wound drain tube. These are also equipped with trocar guards.
  • Manufacturer
    Stryker Instruments Div. of Stryker Corporation

Manufacturer

Stryker Instruments Div. of Stryker Corporation
  • Dirección del fabricante
    Stryker Instruments Div. of Stryker Corporation, 4100 E Milham Ave, Portage MI 49002-9704
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    USFDA