Events

Retiro De Equipo (Recall) de Device Recall Arrow WH02220 Epidural Catheterization Kit with FlexTip Plus(R) 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 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
    57259
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1012-2011
  • Fecha de inicio del evento
    2010-11-11
  • Fecha de publicación del evento
    2011-02-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-07-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95692
  • 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
    Anesthesia conduction kit - Product Code CAZ
  • Causa
    Sterility may be compromised.
  • Acción
    The firm, Arrow International, issued an "URGENT MEDICAL DEVICE RECALL" letter dated November 11, 2010 to their consignees/customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed to check their inventory for the affected products, cease use and distribution, quarantine all affected product immediately, return any affected product freight collect along with the completed form via mail to: Arrow International, Inc., 312 Commerce Place, Asheboro, NC 27203, Attn: Asheboro Quality Assurance Manager, and complete and return the FIELD SAFETY CORRECTIVE ACTION ACKNOWLEDGEMENT AND STOCK STATUS FORM via fax to: 800-343-2935. If you require additional information or clarification regarding this matter, please contact your sales representative, or Arrow's Customer Service Department at 866-396-2111.

Device

Device Recall Arrow WH02220 Epidural Catheterization Kit with FlexTip Plus(R) Catheter
  • Modelo / Serial
    Lot # RF0063961
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution: USA states including IL and LA.
  • Descripción del producto
    Arrow WH-02220 - Epidural Catheterization Kit with FlexTip Plus(R) Catheter || Intended use: Permits acccess to epidural space, Epidural Anesthesia Kit
  • 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