Events

Retiro De Equipo (Recall) de LocatorWand Cover

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 MD, 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
    36466
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0067-2007
  • Fecha de publicación del evento
    2006-10-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2006-12-30
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48697
  • 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
    Locator-Wand Cover - Product Code MMP
  • Causa
    Smiths medical became aware that product returned to them under recall # z-0800-06/ z-0807-06 was inadvertently distributed to consignees after the recall was initiated 03/29/2006. the product was originally recalled because locator wand covers, which are supplied on the outside of port-a-cath and p.A.S. port sterile trays, may have an insufficient seal and product sterility could be compromised.
  • Acción
    An Urgent Product Safety & Recall Notification, dated 09/27/06, was sent to customers via facsimile and phone calls were made. The letter describes the issue and customers are given 3 options to include: use only the sterile tray and discard the wand cover, remove and discard Locator-Wand Cover pouches and request replacement Locator-Wand Covers, or return the entire device for a credit or replacement.

Device

LocatorWand Cover
  • Modelo / Serial
    Lot number M41399
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    CA, FL, MA, MD, OH, OK, TX
  • Descripción del producto
    Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate to the sterile tray containing and identified as PORT-A-CATH P.A.S. PORT Elite Fluoro-Free, Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm O.D. tray. REF 21-4690-24. Contents: Portal with ULTRA-LOCK Connector, Radiopaque PolyFlow polyurethane Catheter 5.8Fr with CATH-FINDER Sensor Wire, Locator-Wand cover, Luer Cap, 20G PORT-A-CATH needle, 18G Blunt needle, Vein Pick, Point-Lok Sharps Safety Device, Product Information. EtO Sterilized. Single Use. Deltec, Inc., St. Paul, MN 55112 U.S.A.
  • Manufacturer
    Smiths Medical MD, Inc.

Manufacturer

Smiths Medical MD, Inc.
  • Dirección del fabricante
    Smiths Medical MD, Inc., 1265 Grey Fox Rd, Saint Paul MN 55112-6929
  • Source
    USFDA