Events

Retiro De Equipo (Recall) de Device Recall Luma Wrap

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 Beevers Manufacturing & Supply, 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
    68803
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2181-2014
  • Fecha de inicio del evento
    2014-07-11
  • Fecha de publicación del evento
    2014-08-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-07-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128768
  • 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
    blanket, neonatal phototherapy - Product Code PDH
  • Causa
    Beevers manufacturing & supply inc. is recalling luma wrap neonatal phototherapy blankets because the product was inadvertently misclassified and marketed without a cleared 510(k) submission from the us fda.
  • Acción
    BMS is contacting their customers and requesting that distributors report the amount of affected product they have in stock, prior to returning affected product. BMS is also asking its distributors to forward the recall notification to its customers to whom affected product was sold. BMS expects those customers to also report to BMS the amount of affected product they have.

Device

Device Recall Luma Wrap
  • Modelo / Serial
    Recalled units include: LW102 (medium), Lot 66812; LW103 (large), Lots 66813 and 30660; and  LW105 (extra large), Lot 67879.  LumaWrap models with an adhesive strip (LW102 and LW103) have a 2-year shelf life.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Product was distributed to US, Germany, Austria, France, Italy, Spain, Australia.
  • Descripción del producto
    Luma Wrap Phototherapy Swaddler is designed to provide centered and comfortable boundaries as a benefit for restive babies in the Neonatal Intensive Care Unit.
  • Manufacturer
    Beevers Manufacturing & Supply, Inc.

Manufacturer

Beevers Manufacturing & Supply, Inc.
  • Dirección del fabricante
    Beevers Manufacturing & Supply, Inc., 850 SW Booth Bend Rd, McMinnville OR 97128-9320
  • Empresa matriz del fabricante (2017)
    Beevers Manufacturing & Supply Inc.
  • Source
    USFDA