Events

Retiro De Equipo (Recall) de Whatman Body Fluid Collection Paper 903

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 Whatman, 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
    53819
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2384-2010
  • Fecha de inicio del evento
    2009-10-29
  • Fecha de publicación del evento
    2010-09-07
  • 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=86584
  • 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
    tubes, vials, systems, serum separators, blood collection - Product Code JKA
  • Causa
    Neonate newborn screening card demographic and filter portion may be detached.
  • Acción
    The firm, Whatman, issued an "URGENT MEDICAL DEVICE CORRECTION" letter dated October 29, 2009, to the customer. The letter described the product, problem and action to be taken by the customer. The letter instructed the customer to: inspect the card and ensure the 903 Paper Portion is firmly and completely fixed to the Demographic portio, prior to recording patient demographic details on the card and obtaining a patient sample; discard the card, obtain a new card and inspect as above, if the 903 Paper Portion of the card partially or completely detaches from the Demographic portion of the card; and to please staple the card stub at two points as specified in the illustration, to prevent any opportunity for 903 paper detachment from the demographic portions. If Whatman customers/users have any questions in relation to this customer notification, please contact, either Product Manager at +1 732 885 6570,email: lili.lee@ge.com or Quality Assurance at +1 207 459 7557, email: heidi.kuell@ge.com.

Device

Whatman Body Fluid Collection Paper 903
  • Modelo / Serial
    Lot: W 071 6820708
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution: CA
  • Descripción del producto
    Whatman Body Fluid Collection Paper- 903 California Newborn Screening Card Ref 110534 || 903 Card are intended for use by healthcare professionals in the collection and in-vitro storage of neonate human blood. The neonate blood is tested to screen the infant for congenital abnormalities of metabolism and other conditions.790
  • Manufacturer
    Whatman, Inc.

Manufacturer

Whatman, Inc.
  • Dirección del fabricante
    Whatman, Inc., 63 Community Drive, Sanford ME 04073
  • Empresa matriz del fabricante (2017)
    General Electric Company
  • Source
    USFDA