Events

Retiro De Equipo (Recall) de CareGuard Mattress Models CG10180 and CG10180A used with IVC and ValueCare Series Beds

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 Invacare 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
    56336
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2402-2010
  • Fecha de inicio del evento
    2007-10-11
  • Fecha de publicación del evento
    2010-09-12
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-06-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93266
  • 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
    Cover, Mattress (Medical Purposes) - Product Code FMW
  • Causa
    In october 2007 invacare corporation, florida recalled careguard mattresses, models cg10180 and cg10180a, associated with ivc bed series full electric beds, semi-electric beds and manual beds and the valuecare bed series semi electric beds, when used with invacare bed rails. affected bed packages are bed24ivc, bed25ivc, bed24ca, and bed25ca. the mattresses when used in combination with the ivc a.
  • Acción
    Consignees were notified of the recall by letter dated October 15, 2007 and entitled "CareGuard Mattresses Provided Since September 2006 In combination with IVC Bed Series Full Electric Beds, Semi-Electric Beds and Manual Beds, and the Value Care Bed Series Semi Electric Bed, and Full and Half-Length Rails". Depending on the mattress usage the consignees were instructed to either: A: 1) Move the bed rail cross bar from the 5th and 6th spring location on the head section of the bed to the 6th and 7th spring location on the head section of the bed in accordance with the enclosed instructions and document your actions on the enclosed tracking sheet. 2) Return of the Product Tracking Report indicating disposition of the recalled product and acknowledgement of receipt of the recall package. 3) The tracking sheet must be sent to Invacare by January 15, 2008 in order for you to receive the $10 credit. or B) 1) contact Customer Service and request part No. 6022, which is a kit that contains a 2" convoluted foam pad, warning label and installation instructions. Testing has shown that the addition of the foam pad on a new mattress with Invacare half rails / bed combination meets the Guidance requirements." 2) When you have completed placing the label and foam topper on all of your affected mattresses, return the tracking sheet to us and we will credit your account $10 for each mattress you have listed. the tracking sheet must be sent to Invacare by January 15, 2008 in order for you to receive the $10 credi

Device

CareGuard Mattress Models CG10180 and CG10180A used with IVC and ValueCare Series Beds
  • Modelo / Serial
    September 2006 through July 2007.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    CareGuard Mattress Models CG10180 and CG10180A used with IVC and ValueCare Series of manual, semi-electric and electric beds. || Mattresses can be identified by looking on the law label tag for the following information: Model # CG10180 or CG10180CA and a BLACK date code with the corresponding month and year of manufacture (i.e. September 2006. October 2006...August 2007). || Manufactured by: Invacare Corp., 2101 East lake Mary Blvd. Sanford, FL 32773. || Affected bed package model numbers: BED24IVC, BED25IVC, BED24CA or BED25CA,
  • Manufacturer
    Invacare Corporation

Manufacturer

Invacare Corporation
  • Dirección del fabricante
    Invacare Corporation, 2101 E. Lake Mary Blvd., Sanford FL 32773
  • Empresa matriz del fabricante (2017)
    Invacare Corporation
  • Source
    USFDA