Events

Retiro De Equipo (Recall) de Katzen" Infusion 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 Corporation.

¿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
    59693
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-3053-2011
  • Fecha de inicio del evento
    2011-08-01
  • Fecha de publicación del evento
    2011-08-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-08-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103349
  • 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
    Wire, Guide, Catheter - Product Code DQX
  • Causa
    Boston scientific is voluntarily recalling one lot/batch of katzen" infusion wires because we have identified that the label on the carton and the inner pouch indicated an incorrect device length. the labels indicate a device length of 180cm while the actual device length is 145cm.
  • Acción
    Boston Scientific sent an "Urgent Medical Device Recall Removal" letter dated August 1, 2011 to all affected customers. The letter described the problem and product being recalled and advised customers to segregate the affected product immediately and return it to Boston Scientific. Boston Scientific requested the completion and return of the Reply Verification Tracking Form. For additional information on this recall call Boston Scientific Quality Systems at (763) 494-1133.

Device

Katzen" Infusion Wire
  • Modelo / Serial
    UPN Code: M001461930. Catalog: 46-193. Batch/Lot Description: 14270326.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    (USA) Nationwide distribution including the states of AZ, AR, CA, CO, FL, GA, IL, IN, NV, NY, NC, OH, PA, RI, and TX.
  • Descripción del producto
    Katzen" Infusion Wire, 0.035 in x 180 cm, || UPN Product No. M001461930, || RED Catalog No. 46-193, || Made in USA 8600. || Boston Scientific. || NW 41 Street, Miami, FL 33166. || Intended for the infusion of therapeutic agents (i.e., heparin, saline, thrombolytic agents, etc) in the peripheral vasculature. The wire allows for the delivery of agents in either a "pulse -spray" or " slow weep" technique.
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

Boston Scientific Corporation
  • Dirección del fabricante
    Boston Scientific Corporation, 1 Scimed Pl, Maple Grove MN 55311-1565
  • Empresa matriz del fabricante (2017)
    Boston Scientific
  • Comentario del fabricante
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    USFDA