Events

Retiro De Equipo (Recall) de Device Recall HydroSil Hydrophilic 12 French Male Length

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 Rochester Medical Corp.

¿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
    51205
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1086-2009
  • Fecha de inicio del evento
    2009-01-14
  • Fecha de publicación del evento
    2009-03-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-04-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=79223
  • 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
    Urological Catheter - Product Code KOD
  • Causa
    Rochester medical observed some magic3 and hydrosil(r) catheter packages in which the catheter was caught in the package seal during the packaging process.
  • Acción
    Consignees were contacted by telephone or in-person visit. The communication provided the reason for the recall and a list of affected products and their lot numbers, and instruction for the removal. Distributors were given instructions to notify their customers in turn. For the customers that were not reached via telephone call or in-person, a letter, "Voluntary recall of magic product samples," was used for the recipients of product samples and sent via e-mail. The letter was dated January 14, 2009 and asked customers to destroy all of their remaining sample inventory of the affected lot numbers.

Device

Device Recall HydroSil Hydrophilic 12 French Male Length
  • Modelo / Serial
    Lot #53606961
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA including states of CA, FL, GA, ID, IL, LA, MD, MA, MI, MN, NJ, NM, NY, OH, PA, and WA and countries of United Kingdom.
  • Descripción del producto
    HydroSil (Intermittent Catheter), Hydrophilic 12 French Male Length REF#63612 || Rochester Medical, Distributed by Rochester Medical Ltd 10 Commerce Way, Lancing West Sussex BN158TA, Sterile R, Rochester and HydroSil are registered trademarks of Rochester Medical Corporation. Rochester Medical Corporation, Stewartville, MN 55976. || Intended for use for bladder management including urine drainage, collection and measurement.
  • Manufacturer
    Rochester Medical Corp

Manufacturer

Rochester Medical Corp
  • Dirección del fabricante
    Rochester Medical Corp, 1 Rochester Medical Dr Nw, Stewartville MN 55976-1647
  • Source
    USFDA