Events

Retiro De Equipo (Recall) de ThermaCare Menstrual 8 Hour Heat Wraps

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 Pfizer Global.

¿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
    56855
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0622-2011
  • Fecha de publicación del evento
    2010-12-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-09-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94656
  • 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
    Pack, hot or cold, disposable - Product Code IMD
  • Causa
    The chemical components contained in the heat wrap may leak directly onto the skin, which could cause skin injury, including burns.
  • Acción
    Wyeth Consumer Healthcare issued an Urgent Voluntary Medical Device Recall letter dated September 24, 2010 to direct accounts, and issued a press release. The firm is removing the product in question from store shelves and asking consumers who have purchased the product to record the lot number, throw the product away in its entirety without opening the foil pouch and call 1 800 232-3383 for replacement. Direct accounts were instructed to remove the affected product from sale and return it immediately. If they further distributed the product they were instructed to notify their customers of the recall and request return of the products to them credit. Instructions were provided in the event consumers inquired about the recall. A prepaid post card was enclosed to record the quantity on hand to be returned.

Device

ThermaCare Menstrual 8 Hour Heat Wraps
  • Modelo / Serial
    Lot number: E06831 (Exp 8/2012); The lot number on the 3 ct cartons may be followed by an "N" or "S", for example, E06831 "N" or E06831 "S"
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution: Throughout the U.S. and Puerto Rico.
  • Descripción del producto
    ThermaCare Menstrual 8 Hour Heat Wraps, 3 count, NDC 0573-3020-02, SKU: 302002, UPC: 3-0573-3020-02-9, Wyeth Consumer Healthcare, P.O. Box 26609, Richmond, VA 23261-6609
  • Manufacturer
    Pfizer Global

Manufacturer

Pfizer Global
  • Dirección del fabricante
    Pfizer Global, 5 Giralda Farms, Madison NJ 07940
  • Empresa matriz del fabricante (2017)
    Pfizer
  • Source
    USFDA