Events

Retiro De Equipo (Recall) de Device Recall Medpro AccuFlo Elastomeric Infusion Device

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 Progressive Medical 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
    59981
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-0081-2012
  • Fecha de inicio del evento
    2011-07-28
  • Fecha de publicación del evento
    2011-10-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-12-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104145
  • 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
    Pump, infusion, elastomeric - Product Code MEB
  • Causa
    The product may have a higher flow rate than specified resulting in over administration of drug solutions to the patients.
  • Acción
    The firm, Progressive Medical, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated July 28, 2011 via email and regular mail to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to discontinue their use; remove the products from inventory and quarantine them; inform their customers to return unused products to Progressive; return the product, and complete and return the RECALL RETURN RESPONSE FORM via fax to 314-961-5786. Progressive customer service will contact the customers to coordinate the return of the goods in question. Should you have any questions, please call 800-969-6331 or email to dsullivan@progressivemedinc.com.

Device

Device Recall Medpro AccuFlo Elastomeric Infusion Device
  • Modelo / Serial
    Lot #100924, Exp. 2015-08, Item CT-0020-270C
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution: USA including states of: FL, KY, PA, VA and WY.
  • Descripción del producto
    Medpro AccuFlo Elastomeric Infusion Device, Model #CT-0020-270C, packaged 12/box. The box label shows the product is Manufactured By: Medpro International (Thailand) Ltd. for Medpro Corporation Pte. Ltd., Singapore. || The devices are intended for patients requiring intravenous, percutaneous, subcutaneous, intra-operative sites or epidural administration of medications.
  • Manufacturer
    Progressive Medical Inc

Manufacturer

Progressive Medical Inc
  • Dirección del fabricante
    Progressive Medical Inc, 11085 Gravois Industrial Ct, Saint Louis MO 63128-2012
  • Empresa matriz del fabricante (2017)
    Progressive Medical Inc
  • Source
    USFDA