Events

Retiro De Equipo (Recall) de Device Recall Tempa DOT

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 Medical Indicators, 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
    65905
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2162-2013
  • Fecha de inicio del evento
    2013-07-10
  • Fecha de publicación del evento
    2013-09-06
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-01-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=120780
  • 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
    Thermometer, clinical color change - Product Code FQZ
  • Causa
    Tempadot products may have been mislabeled.
  • Acción
    The firm, Medical Indicators Inc.sent an "URGENT" Recall letter dated July 10, 2013 and Acknowledgement Form to all distributors/customers via email and Priority Mail with delivery confirmation. The letter described the product, problem and actions to be taken. The customers were instructed to check full & partial cases of the tempadot; open and inspect all 5122NS cases; pull out and quarantine any of the lots found in the 5122NS cases, pending return to medical indicators; if individual Tempadot 100-count boxes of 5122 and 5122NS are stored in different warehouse follow the instructions provided in the letter; if Tempadot 100-count boxes of 5122 were sold to a customer with the affected lots, contact the customer and have them return the product; and complete and return the Recall Return Response Acknowledgement and Receipt Form via mail to: 16 Thomas J Rhodes Industrial Drive, Hamilton NJ, 08619; fax: (609) 587-5636 or email to: www.medicalindicators.com or General Manager at: pbaker@medicalindicators.com. Contact information for any question(s) related to this recall may be addressed to General Manager of Medical Indicators, Inc. at 609-737-1600, extension 204 or email to: pbaker@medicalindicators.com, Mondays through Fridays from 8:00am to 5:00pm EST.

Device

Device Recall Tempa DOT
  • Modelo / Serial
    Lots  06068, 06083, 06112, 06126, 06129, 06138, 06153, 06219, and 06225
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution: USA including states of: CA, GA, FL, IN, NY, NV OH, PA, TN,TX, VA, and WI.
  • Descripción del producto
    Tempa DOT Single-Use Clinical Thermometer || Medical Indicators || Made in U.S.A. by Medical Indicators, Inc. 16 Thomas J Rhodes Industrial Drive, Hamilton, NJ 08619 USA Phone 1.888.737.1601 www.medicalindicators.com || Per 3M website (this product line was recently bought by Medical Indicators from 3M) and labeling in 806, TempaDOT thermometers are individually wrapped, single-use, disposable clinical thermometers for oral or axillary use.
  • Manufacturer
    Medical Indicators, Inc.

Manufacturer

Medical Indicators, Inc.
  • Dirección del fabricante
    Medical Indicators, Inc., 16 Thomas J. Rhodes Industrial Drive, Hamilton NJ 08619
  • Empresa matriz del fabricante (2017)
    Medical Indicators, Inc.
  • Source
    USFDA