Events

Retiro De Equipo (Recall) de Device Recall AMS600B, AMS700B A Magellan Dispenser Tip

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 Micromedics, 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
    56874
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-0345-2011
  • Fecha de inicio del evento
    2010-03-15
  • Fecha de publicación del evento
    2010-11-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-06-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94776
  • 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
    Syringe, irrigating (non dental) - Product Code KYZ
  • Causa
    Micromedics, inc is conducting a product recall on a number of medical device products because of weak seals of the sterile pouches, potentially resulting in a non-sterile product which may cause transmission of disease or infection.
  • Acción
    Micromedics issued a Product Recall letter dated March 15, 2010 to customers, describing the product being recalled, the product sterility issue, and actions to be taken. The letter advised customers to contact Customer service to return any affected product to Micromedics for replacement. Customers can contact Micromedics at 1-800-624-5662 or 651-452-1977 ext. 226 concerning this recall.

Device

Device Recall AMS600B, AMS700B A Magellan Dispenser Tip
  • Modelo / Serial
    Model / Lot #:  AMS600-B / 113501, AMS700-B / 113511, SA-0105 / 114156, SA-3675 / 114453 / 113532, SA-3678 / 114275.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution in the states of CA, CT, DE, FL, GA, ID, IL, IN, MD, MA, MI, MN, NJ, NY, NC, PA, TX, UT, and WI. FRANCE, NETHERLANDS, BELGIUM, UNITED KINGDOM, CANADA, ISRAEL, PERU, SPAIN, IRELAND.
  • Descripción del producto
    AMS600-B, AMS700-B, SA-0105, SA-3675, SA-3678 || Arteriocyte Medical systems, Magellan, Cannula Tip, Catalog Number || AMS600-B,Sterilized by Ethylene Oxide, Rx Only, Manufacturer Micromedics Inc., St. Paul, MN 55121-1385 USA, Distributor: Arteriocyte Medical Systems, Inc., 45 South Street, Hopkinton, MA 01748 USA. || Arteriocyte Medical systems, Magellan, Cannula Tip, Catalog Number || AMS700-B,Sterilized by Ethylene Oxide, Rx Only, Manufacturer Micromedics Inc., St. Paul, MN 55121-1385 USA, Distributor: Arteriocyte Medical Systems, Inc., 45 South Street, Hopkinton, MA 01748 USA. || Fibrijet, Applicator Tip Dual Cannula Malleable 26 ga x3" (7.6cm), Catalog Number SA-0105, Micromedics, Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc. St Paul, MN 55121-1385 USA. || Fibrijet, Mixing Applicator Tip Low Viscosity with Spray Tip, Catalog Number SA-3675, Micromedics, Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc. St Paul, MN 55121-1385 USA. || Fibrijet, Blending Connector with Mixer, Catalog Number SA-3678, Micromedics, Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc. St Paul, MN 55121-1385 USA
  • Manufacturer
    Micromedics, Inc.

Manufacturer

Micromedics, Inc.
  • Dirección del fabricante
    Micromedics, Inc., 1270 Eagan Industrial Rd Ste 120, Eagan MN 55121-1385
  • Empresa matriz del fabricante (2017)
    Nordson Corporation
  • Source
    USFDA