Events

Retiro De Equipo (Recall) de Device Recall SelfCath Pediatric Catheter

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 Coloplast Manufacturing US, 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
    73604
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1525-2016
  • Fecha de inicio del evento
    2016-03-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-10-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144560
  • 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, retention type, balloon - Product Code EZL
  • Causa
    Coloplast corp. is voluntarily recalling a single lot of self-cath pediatric french size ch 06 catheters because a small portion of the lot was identified to have missing eyelets. this recall is based upon a complaint coloplast received regarding a catheter malfunction.
  • Acción
    Coloplast sent an "Urgent Medical Device Recall" letter dated March 22, 2016 to customers. The letter described the problem and the product involved in the recall. Advised consignees to immediately examine, quarantine and return the affected product. If the product has been further distributed, consignees should identify their customers and notify them of the recall. It also requested consignees to complete and return the Acknowledgement Form. For questions contact Coloplast Customer Service directly at 800-533-0464.

Device

Device Recall SelfCath Pediatric Catheter
  • Modelo / Serial
    4464131
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution in the states of: AL, AR, C, FL, IL KY, LA, MD, MA, MI, MN, MO, NJ,NY, NC, OK,OR, PA, TN, TX, VA and WA.
  • Descripción del producto
    Self-Cath¿ Pediatric Catheter Size CH 06, Product # 5044101400, Catakig # 306. || Product Usage: || The Self-Cath intermittent urinary catheter discussed in this document is a pediatric size CH06 French catheter. The catheter is indicated for use by patients with chronic urine retention and patients with a post void residual volume (PVR) due to neurogenic and non-neurogenic voiding dysfunction. The catheter is inserted into the urethra to reach the bladder allowing the urine to drain.
  • Manufacturer
    Coloplast Manufacturing US, LLC

Manufacturer

Coloplast Manufacturing US, LLC
  • Dirección del fabricante
    Coloplast Manufacturing US, LLC, 1601 W River Rd, Minneapolis MN 55411-3431
  • Empresa matriz del fabricante (2017)
    Coloplast A/S
  • Source
    USFDA