Events

Retiro De Equipo (Recall) de Spinal Anesthesia Trays

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
    66351
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0164-2014
  • Fecha de publicación del evento
    2013-11-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-08-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122136
  • 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
    Anesthesia conduction kit - Product Code CAZ
  • Causa
    Visual particulate in the glass ampules of 5% lidocaine hcl and 7.5% dextrose injection, usp, 2 ml ampoule, ndc # 0409-4712-01, hospira lot number 23-227-dk. these ampules are included in certain portex spinal anaesthesia trays.
  • Acción
    Smiths Medical sent an Urgent Recall Notice dated September 23, 2013, to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to inspect their inventory for the affected product and remove from use. Complete the Confirmation Form and return by fax to 603-358-1017 or by email to spinal@smiths-medical.com. Upon receipt of the completed form, a customer service representative would contact them to arrange for exchange of their unused affected devices for credit or replacement. Customers were also instructed to forward the notice to all personnel who need to be aware within their organization. Customers with questions were instructed to contact Smiths Medical's Customer Service Department at 800-258-5361. For questions regarding this recall call 800-258-5361.

Device

Spinal Anesthesia Trays
  • Modelo / Serial
    Lot: 2455104
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including AK, AR, AZ, CA, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, RI, SC, TX, UT, VA, VT, WA, WI, WY.
  • Descripción del producto
    Portex¿ Saddleblock Tray with Drugs  25g Quincke; 4795-20 || The Regional Anesthesia family of products is comprised of sterile (unless otherwise indicated in the product scope), single-use devices designed to perform epidural, spinal, combined epidural/spinal, nerve block, lumbar puncture and regional anesthesia procedures. The spinal products are comprised of spinal needles, introducer needles and accessories required to perform a spinal procedure.
  • Manufacturer
    Smiths Medical ASD, Inc.

Manufacturer

Smiths Medical ASD, Inc.
  • Dirección del fabricante
    Smiths Medical ASD, Inc., 10 Bowman Dr, Keene NH 03431-5043
  • Empresa matriz del fabricante (2017)
    Smiths Group Plc
  • Source
    USFDA