Events

Retiro De Equipo (Recall) de THERA PEARL 3in1 BREAST THERAPY

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 Lansinoh Laboratories 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
    63390
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0784-2013
  • Fecha de inicio del evento
    2012-08-14
  • Fecha de publicación del evento
    2013-02-04
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-03-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115101
  • 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, reuseable - Product Code IME
  • Causa
    The spanish translation on the instructions for use (ifu) insert and product package for hot and cold packs has incorrect heating instructions which would cause product to over heat.
  • Acción
    Lansinoh Laboratories, Inc. sent an Urgent Product Recall letter dated August 14, 2012, to all affected customer. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to stop distributing and quarantine the affected product. Customers were informed that a credit would be issued for the affected product and they were asked to mail the postage paid Business Reply Card even if they do not have the affected product. If necessary call 1-877-366-1182 to arrange pickup. For questions customers were instructed to call the Customer Service Center at 1-800-292-4794. For questions regarding this recall call 703-299-6477.

Device

THERA PEARL 3in1 BREAST THERAPY
  • Modelo / Serial
    Lot Numbers 100/12/01, 116/12/01, 108/12/01, 109/12/01, 149/12/01
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution, including the states of TX, CA, NJ, NY, SD, RI, WV, IL PA, NC and MN.
  • Descripción del producto
    THERA PEARL 3-in-1 BREAST THERAPY, 2 hot and cold packs in plastic box. || The Thera Pearl 3-in-1 Breast Therapy is a reusable therapeutic hot and cold pack for use with pain, swelling, engorgement, plugged ducts or mastitis associated with breast feeding or to help encourage let-down while using a breast pump.
  • Manufacturer
    Lansinoh Laboratories Inc

Manufacturer

Lansinoh Laboratories Inc
  • Dirección del fabricante
    Lansinoh Laboratories Inc, 333 N Fairfax St Ste 400, Alexandria VA 22314-2632
  • Empresa matriz del fabricante (2017)
    Pigeon Corp.
  • Source
    USFDA