Events

Retiro De Equipo (Recall) de Device Recall The Cure Pediatric Catheter 10Fr

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 Cure Medical LLC.

¿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
    69737
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0496-2015
  • Fecha de inicio del evento
    2014-11-11
  • Fecha de publicación del evento
    2014-12-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-04-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131446
  • 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
    Catheter, straight - Product Code EZD
  • Causa
    Some of the intermediate boxes within lot 140417-3, were labeled as p8, a french size 8 pediatric catheter but actually contain p10, french size 10 pediatric catheters. trying to use a p10 catheter for bladder drainage, where p8 catheters have been prescribed, may result in acute urinary retention; and, forced attempts to insert the french size 10 catheter lead to urethral trauma.
  • Acción
    Cure Medical sent Urgent: Medical Device Correction and Removal Notification, dated November 11, 2014, to customers. The letter identified the affected product and the reason for the recall. Customers were asked to immediately quarantine all cases of P10 catheters, with Lot Number 140417-3, and destroy any boxes that are labeled as P8, Lot 140410-3 and contact us for replacement products. Additionally, if any cases of P10, Lot 140417-3 products or boxes of P8 products, Lot Number 140410-3 were further distributed, those customers were to be identified and notified of the problem via the enclosed letter, which includes instructions on what to do with any affected product. Cure Medical, LLC will work in cooperation with customers to cover expenses associated with this action. Customers were to complete and return the enclosed response form as soon as possible. If there are any questions, customers are to call Carole Harris at 949-723-0364, Monday-Friday, between 09:30 am and 05:00pm Pacific Time.

Device

Device Recall The Cure Pediatric Catheter 10Fr
  • Modelo / Serial
    Lot Number: 140417-3
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    Pediatric, 10Fr, Intermittent Urinary Catheters || Model: P10 || Pouch Label UPC (P10) *+M405P100C* || Intermediate Box Label UPC (P10) *+M405P103F* || Carton Label UPC (P10) *+M405P105H* || The product is distributed individually or in intermediate boxes containing 30 individual, sterile packaged catheters (PA/PE film and dialyzing paper pouches). || There are 30 catheters packaged in sterile pouches that are placed into an intermediate box, 10 of these intermediate boxes packaged into one case. || Intended to be used by pediatric males and females for the purpose of bladder drainage
  • Manufacturer
    Cure Medical LLC

Manufacturer

Cure Medical LLC
  • Dirección del fabricante
    Cure Medical LLC, 3700 Newport Blvd Ste 301, Newport Beach CA 92663-3946
  • Empresa matriz del fabricante (2017)
    Cure Medical Llc
  • Source
    USFDA