Events

Retiro De Equipo (Recall) de Device Recall Catheter, Intravascular, Therapeutic, ShortTerm

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
    74898
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2774-2016
  • Fecha de inicio del evento
    2016-02-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-10-18
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148713
  • 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,intravascular,therapeutic,long-term greater than 30 days - Product Code LJS
  • Causa
    Notification of component molding abnormality by supplier used to package certain arrow select kit (ask) products.
  • Acción
    The firm, Arrow International, sent an "Urgent Medical Device Recall Notification" letter dated 02/19/2016 via FedEx 2-day delivery to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately discontinue use and quarantine any of the affected products found; return product-a customer service representative will contact you with a RGA number and instructions; and complete and return the enclosed Recall Acknowledgement Form via fax to 1-855-419-8507 Attn: Customer Service or email to recalls@teleflex.com, even if you do not have no affected product. If you have any questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.

Device

Device Recall Catheter, Intravascular, Therapeutic, ShortTerm
  • Modelo / Serial
    Lot/Batch Numbers:  23F15L0662,23F15J0260,23F15K0983,23F15G0159,23F15J1102,23F15J0259 23F15C1225,23S15G0973,23F15H1033,23F15F0358,23F15K0345,23F15D1514 23F15C1226,23F15H0919,23F15E1091,23F15H0014,23F15D0241,23F15J0533 23F15E1094,23F15H0020,23F15H0740,23F15K1009,23F15J0431,23F15F1836 23F15H0857,23F15K0012,23F15M0313,23F15G0871,23F15J0285
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    US Distribution to states of: NC, OH, FL, and MD.
  • Descripción del producto
    Catheter, Intravascular, Therapeutic, Short-Term Less than 30 days || The Arrow CVC is indicated to provide short-term (<30 days) central venous access for treatment of diseases or conditions requiring central venous access.
  • Manufacturer
    Arrow International Inc

Manufacturer

Arrow International Inc
  • Dirección del fabricante
    Arrow International Inc, 2400 Bernville Rd, Reading PA 19605-9607
  • Empresa matriz del fabricante (2017)
    Teleflex Incorporated
  • Source
    USFDA