Events

Retiro De Equipo (Recall) de GSK

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 GSK Consumer Healthcare.

¿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
    74030
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-2148-2016
  • Fecha de inicio del evento
    2016-04-25
  • Fecha de publicación del evento
    2016-07-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-07-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146010
  • 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
    Breathing - Nasal Strips - Product Code N/A
  • Causa
    Some cartons used in the secondary packaging of breathe right clear, large, 30 ct. nasal strips were incorrectly labeled for cartons intended for the au/nz market.
  • Acción
    GSK Consumer Healthcare sent an Urgent - Product Recall Letter dated April 4, 2016, to all affected customers and an updated recall letter dated April 25, 2016, via FedEx. The recall letters identified the product and problem. The April 25, 2016, was sent to further clarify, the lot number on the Breathe Right carton. The customers were asked to immediately examine their inventory, quarantine and cease distribution of the specific lot of the affected product. Customers were asked to carry out a physical count and record the data on the response form. The response form should be returned to GSK within five (5) business days, even if you do not have the recalled lot. The response form should be faxed to (336) 499-8795. If customer needs shipping assistance or questions about the recall process, they can call 1-844-722-2104, and refer to Event Number 535STRIPS16. If any customer has questions, they can direct them to GSK Consumer Healthcare Consumer Relations team at 800-858-6673.

Device

GSK
  • Modelo / Serial
    Shipper case lot #8008580, Retal Carton Lot #4543U8008580
  • Distribución
    US Nationwide
  • Descripción del producto
    Breathe Right Clear, 30 ct. carton., UPC 7-57145-00246-7 (US), UPC 9-300673-871749 (AU/NZ)
  • Manufacturer
    GSK Consumer Healthcare

Manufacturer

GSK Consumer Healthcare
  • Dirección del fabricante
    GSK Consumer Healthcare, 184 Liberty Corner Rd Ste 200, Warren NJ 07059-6868
  • Empresa matriz del fabricante (2017)
    Glaxosmithkline Plc
  • Source
    USFDA