Events

Retiro De Equipo (Recall) de Device Recall Infusion 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 Zevex International, 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
    57829
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1445-2011
  • Fecha de inicio del evento
    2011-01-24
  • Fecha de publicación del evento
    2011-02-25
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-09-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97541
  • 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
    Pump, infusion - Product Code FRN
  • Causa
    Defect in tubing may trigger false air-in-line warning.
  • Acción
    The firm, MOOG, sent an "Expansion of Moog/Curlin Ambulatory Pump Administration Set Recall" letter dated May 2, 2011 to its customers. This letter informed the customers that this recall has been expanded to included specific lot numbers of Curlin model ambulatory infusion administration sets. The customers were instructed to follow the outlined process in the letter: remove suspect product code from inventory, contact MOOG Customer Service at 1-800-970-2337, prompt #7, contact your distributor to arrange replacement product, request a shipping return label as per the distributor's process and ship back to their location and follow the temporary solution outlined in the letter. Moog Customer Service will provide a call tag for convenient product return. If you have any questions contact MOOG Customer Service at 1-800-970-2337. The firm, MOOG, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated January 24, 2011 to all customers. The letter described the product, problem and actions to be taken by the customers. The customers were instructed to remove suspect product code from inventory; contact their distributor to arrange replacement product, if purchased from distributor and request shipping return label per distributors process and ship back to their location or contact MOOG Customer Service at 800-970-2337, prompt #7, if purchased directly from MOOG and MOOG Customer Service will provide a call tag for convenient product return; follow the temporary solution provided until replacements are administered; and complete and return the MEDICAL DEVICE CORRECTION REPLY FORM in the self addressed envelope provided. If you have any questions, contact MOOG Customer Service at 800-970-2337.

Device

Device Recall Infusion Administration Set
  • Modelo / Serial
    ***EXPANDED*** Additional Lots Added 05/12/2011: CF1021808, CRF10082001, CRF10084001, CRF10085001, CRF10089001, CRF10140001, CRF10161002.  Lot Codes: CF1019019, CF1019023, CF1021804, CF1022206, CRF10100001, CRF10102001, CRF10104001, CRF10139003, CRF10160002, CRF10161003, D004617, D005006, D006004, D011801, D012439, D013007, D014707, D015905, D016003, D016604, D016713, D017419, D018101, D019323 D020024, D020235, D020236, D020237, D021601, D027014.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: USA including states of: AR, CA, FL, IA, KS, MS, NE, NY, OH, OK, TN, TX, and UT; and countries including: Australia, Croatia, France, Germany, Kuwait, New Zealand, Qatar, Saudi Arabia, South Africa, United Arab Emirates, and UK.
  • Descripción del producto
    Curlin Infusion Administration Set, REF 340-4128-V, Sterile EO, Zevex, Inc., 4314 Zevex Park Lane, Salt Lake City, UT 84123. || The Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories, provide a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications.
  • Manufacturer
    Zevex International, Inc.

Manufacturer

Zevex International, Inc.
  • Dirección del fabricante
    Zevex International, Inc., 4314 Zevex Park Ln, Salt Lake City UT 84123
  • Empresa matriz del fabricante (2017)
    Moog Inc
  • Source
    USFDA