Events

Retiro De Equipo (Recall) de Device Recall ARROW, ARROWGARD BLUE PLUS PRESSURE INJECTABLE QUADLUMEN CVC KIT

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
    74362
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2136-2016
  • Fecha de inicio del evento
    2016-06-02
  • Fecha de publicación del evento
    2016-07-06
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-08-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147271
  • 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,short-term less than 30 days - Product Code FOZ
  • Causa
    Arrow is recalling these products due to the possibility that although the kit is labeled as containing a 20 cm catheter, a 16 cm catheter may be packaged in the kit.
  • Acción
    Arrow mailed an Urgent Medical Device Recall Notification letter to customers requesting they immediately discontinue distribution and quarantine any products with the affected lot numbers. A Recall Acknowledgement Form was included with the notification letter for customers to complete and email to recalls @teleflex.com indicating the amount of product on hand.

Device

Device Recall ARROW, ARROWGARD BLUE PLUS PRESSURE INJECTABLE QUADLUMEN CVC KIT
  • Modelo / Serial
    Device Listing # D040746, FDA Product Code FOZ, Product Code: ASK-45854-PUC, ASK-45854-PSFM, ASK-42854-PCSM and ASK-42854-PBW4 Lot # 23F15F1786, 23F15F1862, 23F15G0818, 23F15J0162, 23F15H0460, 23F15F0943, 23F15G0729, 23F15J1084
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution: in the states of MA, CA, IL, TN, IL
  • Descripción del producto
    ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER. || Product Usage: || Indicated to provide short-term (<30 days) central venous access for treatment of diseases or conditions requiring cental venous access including, but not limited to: multiple infusions of fluids, medications, or chemotherapy, infusion of fluids that are hypertonic, hyperosmolar, or have divergent pH values, frequent blood sampling or blood/blood component infusions, infusion of incompatible medications, central venous pressure monitoring, lack of usable peripheral IV sites, replacement of multiple peripheral sites for IV access and injection of contrast media.
  • 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