Events

Retiro De Equipo (Recall) de Reprocessed Balloon Inflation 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 Sterilmed 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
    49510
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0546-2009
  • Fecha de inicio del evento
    2008-08-08
  • Fecha de publicación del evento
    2009-01-13
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-04-26
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73669
  • 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
    Balloon Inflation Device - Product Code NKU
  • Causa
    Sterimed, inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. the removal is being conducted because the possibility exists that some of the pouches were not properly sealed on one end. a breach in packaging seal or a failure in packaging integrity has the possibility of risk to the patient in terms of transmitting organisms capable.
  • Acción
    Consignees were notified of the recall via verbal communication in person by on-site technician and or their local sales representative on 8/8/08. Others were contacted via fax or e-mail followed by on-site visits 8/11/08. SteriMed also provided consignees (Materials Manager/Risk Manager) with a "Urgent Product Removal" recall letter (August 14, 2008) in person informing them of the potential of receiving affected product. Included in the Product Removal Notification was a Customer Reply Form to inventory quantity of product received and quantity returned. Contact SterilMed, Inc. at 1-888-541-0078 for assistance.

Device

Reprocessed Balloon Inflation Device
  • Modelo / Serial
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, MA, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, WA, WI, and WV OUS: CANADA
  • Descripción del producto
    Balloon Inflation Device || Model #'s: || MED15-105 || MED15-106 and || SCI04527-01 || The reprocessed Balloon inflation device is intended for use with balloon dilatation catheters to create and monitor pressure in the ballon and to deflate the ballon.
  • Manufacturer
    Sterilmed Inc

Manufacturer

Sterilmed Inc
  • Dirección del fabricante
    Sterilmed Inc, 11400 73rd Ave N Ste 100, Osseo MN 55369-5562
  • Empresa matriz del fabricante (2017)
    Johnson & Johnson
  • Source
    USFDA