Events

Retiro De Equipo (Recall) de Device Recall AirLife(TM) Arterial Blood Gas (ABG) Sampling 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 Vyaire Medical.

¿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
    77845
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-3080-2017
  • Fecha de inicio del evento
    2017-07-18
  • Fecha de publicación del evento
    2017-08-28
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=158028
  • 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
    Arterial blood sampling kit - Product Code CBT
  • Causa
    Lot #0001047501 of the 9025rhtr abg sampling kits have been manufactured containing the incorrect sub-assembly which includes a larger needle (23 gage, 1" needle), larger syringe (3ml), and larger amount of heparin (113iu), than what is intended for the kit.
  • Acción
    The firm, Vyaire Medical, sent an "URGENT RECALL NOTIFICATION" letter dated 07/18/2017 to its consignees. The letter described the product, problem and actions to be taken. Thee consignees were directed to inspect their current inventory and remove the recalled lot. Distributors and direct consignees were instructed to complete the Customer Response Form and return to GMB-GLB-ALFieldActions and destroy the product. If you wish to obtain credit/replacement contact Vyaire Customer Support at (800) 323.9008 (option #1) Monday-Friday 8:00am CST - 5:oopm CST. Distributors were instructed to notify their customers and have them respond directly to the distributor. For any additional questions and support concerning this voluntary Recall, please contact Clinical Risk Coordinator, at (224)706-6830 or Lindy.Schenning@Vyaire.com.

Device

Device Recall AirLife(TM) Arterial Blood Gas (ABG) Sampling Kit
  • Modelo / Serial
    Lot Number 0001047501
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution- Nationwide distribution to states of: FL, OK, VA, MI, TH, NM, MA, MO, WA, AND country of: Australia.
  • Descripción del producto
    AirLife(TM) Reduced Heparin ARTERIAL BLOOD SAMPLER, REF 9025RHTR, 1ML SYRINE 25G 5/8", LUER SLIP PROTECTIVE SHEATH, 3.2 IU, STERILE R, Rx ONLY, CAREFUSION || Lot #0001047501 of the 9025RHTR ABG sampling kits have been manufactured containing the incorrect sub-assembly which includes a larger needle (23 Gage, 1" needle), larger syringe (3mL), and larger amount of heparin (113IU), than what is intended for the kit.
  • Manufacturer
    Vyaire Medical

Manufacturer

Vyaire Medical
  • Dirección del fabricante
    Vyaire Medical, 75 N Fairway Dr, Vernon Hills IL 60061-1845
  • Empresa matriz del fabricante (2017)
    Vyaire Holding Company
  • Source
    USFDA