Retiro De Equipo (Recall) de Device Recall Portex Arterial Blood Sampling Line Draw Syringes

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 Smiths Medical ASD, 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
    66837
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1187-2014
  • Fecha de inicio del evento
    2013-11-22
  • Fecha de publicación del evento
    2014-03-12
  • Estado del evento
    Open, Classified
  • País del evento
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
  • 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
    Tubes, vials, systems, serum separators, blood collection - Product Code JKA
  • Causa
    Issue with the plunger tip of the portex¿ arterial blood sampling line draw syringes.
  • Acción
    Smiths Medical sent an Urgent Field Safety Notice dated November 22, 2013, to all affected consignees via FedEx beginning on November 23, 2013. Distributors were instructed to notify their customers. Customers were instructed to inspect their inventory for the affected product and quarantine the affected syringes. Complete and return the attached Urgent Field Safety Notice Confirmation Form by fax to 603-358-1017 or by email to LineDraw@smiths-medical.com. Upon receipt of the completed form, a customer service representative will contact them to arrange for exchange of their unused affecte devices for credit or replacement. Customers were instructed to forward the notice to all personnel who need to be aware within their organization and to any organization where the potentially affected devices have been transferred. Customers were instructed to report any issues with the product to Smiths Medical's Global Complaint Department at 1-866-216-8806 or globalcomplaints@smiths-medical.com. For questions regarding this recall call 603-352-3812.

Device

  • Modelo / Serial
    2476330 2476331 2485112 2485113 2485115 2493970 2493971 2493972 2506817 2511213 2525787 2529542 2536822 2538273 2542763 2459801 2467733 2467734
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV. Internationally to Australia, Austria, Belgium, Belize, Brazil, Canada, Czech Republic, Denmark, England, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Netherlands, Norway, Poland, Scotland, Spain, and Sweden.
  • Descripción del producto
    4043E: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device (for sale in Europe only) || Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The product is not for injection.
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    Smiths Medical ASD, Inc., 10 Bowman Dr, Keene NH 03431-5043
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA