Events

Retiro De Equipo (Recall) de Biosense Webster's Reprocessed SOUNDSTAR eco Diagnostic Ultrasound Catheters

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 STERILMED, 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
    69337
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0059-2015
  • Fecha de publicación del evento
    2014-10-09
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-08-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130259
  • 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
    Reprocessed intravascular ultrasound catheter - Product Code OWQ
  • Causa
    Sterilmed, a division of johnson & johnson medical nv/sa (sterilmed), has become aware of an issue affecting certain lots of reprocessed soundstar® eco diagnostic ultrasound catheters for which sterilmed is the reprocessor and biosense webster is the distributor. sterilmed determined that the units of these lots were incorrectly processed and as a result when the affected catheter is conne.
  • Acción
    Sterilmed sent an "Field Notification" letter dated September 22, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Actions requested on your part: 1. Read the Description of the Problem section below carefully. 2.Immediately identify and set aside all units from the affected lots of product listed above in a manner that ensures the affected product will not be used. 3. Maintain a copy of this letter with the affected product. 4. Review, complete, sign and return the attached Field Removal Certification Form in accordance with the instructions listed on the form. 5. Arrange for return of any impacted units from the provided list of affected Reprocessed SOUNDSTAR¿ eco Diagnostic Ultrasound Catheters that you may have in your inventory per the instructions on the Field Removal Certification Form. 6. Pass on this notice to anyone in your facility that needs to be informed. 7. If any of the affected Reprocessed SOUNDSTAR¿ eco Diagnostic Ultrasound Catheters have been forwarded to another facility, contact that facility and arrange for the return. 8. Maintain awareness of this notice until all affected product with lot numbers listed above has been returned to Biosense Webster. For questions related to this issue and product return please contact your Biosense Webster sales representative. For further questions please call (763) 488-3400.

Device

Biosense Webster's Reprocessed SOUNDSTAR eco Diagnostic Ultrasound Catheters
  • Modelo / Serial
    Lot Numbers: 1717945, 1721574, 1721575 and 1723123  Catalog Nos: M-5723-115, Model Number BIO10438577
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Distribution including the states of WA and CA.
  • Descripción del producto
    Biosense Webster's Reprocessed SOUNDSTAR¿ eco Diagnostic Ultrasound Catheters, Catalog Nos: M-5723-115, Model Number BIO10438577.
  • Manufacturer
    STERILMED, INC.

Manufacturer

STERILMED, INC.
  • Dirección del fabricante
    STERILMED, INC., 11400 73rd Ave N, Maple Grove MN 55369-5561
  • Empresa matriz del fabricante (2017)
    Johnson & Johnson
  • Source
    USFDA