Events

Retiro De Equipo (Recall) de Device Recall CADD High Volume Administration Set

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
    60883
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0775-2012
  • Fecha de inicio del evento
    2011-12-09
  • Fecha de publicación del evento
    2012-01-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-11-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106706
  • 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
    Set, administration, intravascular - Product Code FPA
  • Causa
    Smith medical has become aware of a small number of customer reports regarding occlusions/high pressure alarms with the use of one lot of cadd high volume administration sets. expanded: smiths medical became aware that an additional product reorder no. 21-738-01 and lot no. 21x221 are also being recalled for receiving reports regarding occlusion/high pressure alarms with the use of these set.
  • Acción
    Consignees were sent a Smiths Medical "Urgent Field Safety Notice" letter dated January 04, 2011. The letter was addressed to Risk/ Safety Managers, Clinicians, Nursing, Pharmacy, Pain Management and Anesthesia Professionals, Distributors and other users of these devices. The letter described the details on affected devices, Advise on Action to be Taken by the User and distributor and Transmission of this Urgent Field Safety Notice. Requested consignees to inspect their inventory and remove affected product and to complete and return the attached Confirmation Form. EXPANDED: The additional devices were distributed 12/14/2011 thru 1/27/2012. An Urgent Medical Device letter, dated 3/16/2012, was sent to customers beginning 3/16/2012. The letter identified the additional affected product, described what the issue is and asked that customers return all unused sets to Smiths Medical for credit or replacement. Also, the customer was asked to complete and return an Urgent Medical Device Recall Confirmation Form. If the customer is a distributor, they were asked to pass along the information to their customers.

Device

Device Recall CADD High Volume Administration Set
  • Modelo / Serial
    Lot 21X222 EXPANDED: Lot 21X221
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution -- AZ, CA, FL, GA, IL, KS, LA, ME, MA, NC, OR, PA,SC, TX, VA, WA, and WI. EXPANDED to include AR, CO, IA, IN, MD, MI, MN, MO, NJ, OH, OK, TN, WV and Canada.
  • Descripción del producto
    CADD¿ High Volume Administration Set, REF 21-7081V-01, Sterile EO, Rx only, Made in Mexico, Smith Medical ASD, Inc., 1265 Grey Fox Road, St Paul, Minnesota 55112. Designed for use with CADD pumps to allow fluid delivery from an IV bag. EXPANDED: Catalog No./ REF 21-7381-01
  • Manufacturer
    Smiths Medical ASD, Inc.

Manufacturer

Smiths Medical ASD, Inc.
  • Dirección del fabricante
    Smiths Medical ASD, Inc., 1265 Grey Fox Rd, Saint Paul MN 55112-6929
  • Empresa matriz del fabricante (2017)
    Smiths Group Plc
  • Source
    USFDA