Events

Retiro De Equipo (Recall) de Device Recall Boston Scientific PT2 Guide Wire

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 Boston Scientific.

¿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
    36201
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-1539-06
  • Fecha de inicio del evento
    2006-08-31
  • Fecha de publicación del evento
    2006-09-29
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2007-06-26
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48305
  • 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
    Guide Wire - Product Code DQX
  • Causa
    The pt2 j-tip labeled guide wires may be missing the pre-formed j-tip. as a result, guide wires may have a straight tip instead of a pre-formed j-tip.
  • Acción
    An Urgent Medical Device Recall letter, dated 08/31/06, was sent to affected customers. The letter describes the issue,states that distribution or use of affected product should cease immediately and replacement product will be issued for all returned devices. A Reply Verification Tracking Form is asked to be completed and returned to Boston Scientific.

Device

Device Recall Boston Scientific PT2 Guide Wire
  • Modelo / Serial
    Single Pack - Outer Box UPN H7492893102J0, Inner Pouch UPN H7493893102J0 with the following Outer Box Batch number / Inner Pouch Batch number: 8616992/8498451; 8634476/8576268; 8637834/8592512; 8642641/8542687; 8687373/8644753; 8687380/8620072; 8693389/8644751.   5-pack - Outer Box UPN H7493893102J2, Inner Pouch UPN H7493893102J0 with the following Outer Box Batch number / Inner Pouch Batch number: 8616993/8498451; 8619932/8428652; 8634477/8576268; 8637835/8592512; 8642642/8542687; 8687374/8644753; 8687381/8620072; 8693471/8644751; 8745684/8677736.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution --- including states of AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, NC, NE, NJ, NM, NV, OH, OK, PA, SC, TN, TX, WI, WV and Puerto Rico and countries of Austria, Belgium, Bulgaria, Chile, Columbia, Czech Republic, Dominican Republic, Egypt, Finland, France, Germany, Greece, Hungary, Italy, Lithuania, Malaysia, Mexico, Norway, Pakistan, Poland, Portugal, Russia, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Arab Emirates, United Kingdom, Venezuela.
  • Descripción del producto
    Boston Scientific PT2 Light Support Guide Wire 300cm J-Tip, Catalog Number 38931-02 . Sold in single pack and 5-pack. PTCA Guide Wire with Hydrophilic Coating. Boston Scientific Guide Wires are steerable guide wires available in a variety of lengths and diameters. The distal tip is shapeable, or, alternatively, is available in a preshaped ''J'' tip. Made in USA.
  • Manufacturer
    Boston Scientific

Manufacturer

Boston Scientific
  • Dirección del fabricante
    Boston Scientific, 1 Scimed Pl, Maple Grove MN 55311-1565
  • Source
    USFDA