Events

Retiro De Equipo (Recall) de Device Recall Arrow

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 Arrow International 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
    69938
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1007-2015
  • Fecha de inicio del evento
    2013-02-04
  • Fecha de publicación del evento
    2015-01-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-10-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132005
  • 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, hemodialysis, implanted - Product Code MSD
  • Causa
    The tunneling sheath packaged within the kits can crack during placement. if the tunneling sheath cracks, it can cause a delay in treatment for the time it takes to retrieve a replacement kit.
  • Acción
    An Urgent Medical Device Recall Notification letter, dated February 4, 2014, was sent to direct consignees that identified the product, problem, and action to be taken. Customers were asked to discontinue use and quarantine affected inventory. The Recall Acknowledgement form should be completed and faxed back to 1-800-343-2935. A customer service representative will contact customers with a Return Goods Authorization (RGA) Number and provide instructions for the return of the product. Customers are asked to contact their local sales representative or Customer Service at 1-800-343-2935 with questions.

Device

Device Recall Arrow
  • Modelo / Serial
    Lot numbers: RF2095946, RF2056557, RF2058764, RF2060829,  RF2084897, RF2084162, RF2071325,RF2060831, RF2083836, RF2096027, RF2107409, RF2108329, RF2119933, RF2060836, RF2060899, RF2083837,  RF2084898, RF2107410, RF2108324, RF2071317, RF2121827, RF2058355,  RF2060414, RF2108326, RF2060811, RF2110441, RF2069798, RF2121821,  RF2069964, RF2122497, RF2110442, RF2058357, RF2119935, RF2108330,  RF2121820, RF2057719, RF2056545, RF2111259, RF2096348.
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution -- US and Canada.
  • Descripción del producto
    The Arrow Edge Hemodialysis Catheterization Set Long-Term Access and NextStep Antegrade Hemodialysis Catheterization Set, Long-Term Access, part numbers: AC-15192-SFX, AC-15232-SFX, AC-15272-SFX, AC-15312-SFX, AC-15422-SFX, CS-15192-SFX, CS-15192-SFXM, CS-15232-SFX, CS-15242-I, CS-15272-SFX, CS-15282-I, CS-15312-SFX, CS-15322-I, CS-15362-I, CS-15422-SFX, CS-15502-SFX, CS-15552-I, CSD-15242-I, CSD-15282-I, and CSD-15322-I. || The Arrow Edge Hemodialysis Catheterization Set and NextStep Antegrade Hemodialysis Catheterization Set is indicated for use in attaining long- term vascular access for hemodialysis and apheresis.
  • Manufacturer
    Arrow International Inc

Manufacturer

Arrow International Inc
  • Dirección del fabricante
    Arrow International Inc, 2400 Bernville Road, Reading PA 19605
  • Empresa matriz del fabricante (2017)
    Teleflex Incorporated
  • Source
    USFDA