Events

Retiro De Equipo (Recall) de Device Recall Fisher & Paykel CPAP Mask

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 Fisher & Paykel Healthcare Inc.

¿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
    36955
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0974-2007
  • Fecha de inicio del evento
    2006-11-24
  • Fecha de publicación del evento
    2007-06-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-03-26
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49665
  • 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
    CPAP mask - Product Code BZD
  • Causa
    Plastic tabs incorporated into the connector components of these cpap masks may break off if they are not cleaned in accordance with the instructions for use. in the event of a tab breaking off, it may enter the cpap system air path and there is an extremely remote possibility that the broken tab may then enter the patient's nasal cavity or mouth. masks manufactured since april 2006 do not feat.
  • Acción
    Fisher & Paykel Healthcare Inc. commenced sending out letters by mail to consignees the week commencing 4 December 2006 advising consignees to quarantine and destroy affected product. A faxback form was also be provided for consignees to advise Fisher & Paykel Healthcare of quarantined and destroyed stock. The firm will supply consignees with replacement product as determined from completed faxback information. The firm will collate responses from consignees and will follow up with a letter to consignees who do not respond within a month of initial mail-out. The firm will then make telephone contact with any consignees who do not respond within a month of the second mail-out. Fisher & Paykel Healthcare Inc. estimated the completion of this voluntary recall by April 2007.

Device

Device Recall Fisher & Paykel CPAP Mask
  • Modelo / Serial
    Lot Numbers for Part Numbers: 400HC202 (lot #s: 040802 to 051222),400HC203 (lot #s: 040719 to 051103), 400HC209 (lot #s: 041108 to 050920), 400HC502 (lot #s: 040825 to 060201), 400HC503 (lot #s:040830 to 051028), 400HC505 (lot #s: 050223 to 050726), 400HCHC510 (lot #s: 051007 to 051028) , 900HC402 (lot #s: 010918 to 060203), 900HC405 (lot#s: 030924 to 030925), 900HC406 (lot #s: 031110 to 060403), 900HC412 (lot #s: 020108 to 060203), 900HC441 (lot #s: 031110 to 060424) & 900HC463 (lot #s: 020108 to 040604)
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide
  • Descripción del producto
    Fisher & Paykel Spares CPAP Mask and Connectors, Part Numbers: 400HC202 (Elbow non-diffuser holes),400HC203 (Elbow + vent NR valve), 400HC209 (Oracle 452 flexitube kit vent NR), 400HC502 (HC407 mask no headgear), 400HC503 (HC431 mask no headgear), 400HC505 (Infinity HC481 mask base), 400HCHC510 (HC406 mask no headgear) , 900HC402 (Aclaim mask no headgear), 900HC405 (HC405 sleep lab mask kit), 900HC406 (HC405 mask no headgear), 900HC412 (Aclaim flexitube kit), 900HC441 (Elbow diffuser and swivel) & 900HC463 (HC451 flexitube kit). CPAP masks.
  • Manufacturer
    Fisher & Paykel Healthcare Inc

Manufacturer

Fisher & Paykel Healthcare Inc
  • Dirección del fabricante
    Fisher & Paykel Healthcare Inc, 15365 Barranca Parkway, Irvine CA 92618
  • Source
    USFDA