Events

Retiro De Equipo (Recall) de IFlow ONQ with SelectAFlow Pumps

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 I-Flow 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
    59148
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2860-2011
  • Fecha de inicio del evento
    2011-04-15
  • Fecha de publicación del evento
    2011-07-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-08-09
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=101372
  • 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
    Infusion Pump, Elastomeric - Product Code MEB
  • Causa
    The recall was initiated because i flow became aware that a small percentage of on-q pump with select a flow may develop a minor leak with a flow rate controller. there may be consequences for the patient, such as under delivery of pain medication or the need to prematurely remove the pump, which would result in loss of the pain treatment provided by the pump.
  • Acción
    I-Flow Corporation sent an "Important Voluntary Market Withdrawal Notice" dated May 12, 2011 to all affected customers. The letter provides the customers with an explanation of the problem identified and an action to be taken. Customers were instructed to quarantine and return all impacted products within their facilities. Customers were instructed to respond with in 5 days of receiving the Market Withdrawal Notice and fax it to (949) 206-2663. Customers with additional questions, were instructed to call I-Flow Customer service at (800) 448-3569 (8-5pm, Pacific Standard time) or I-Flow 24 hour technical support line (800) 444-2728.

Device

IFlow ONQ with SelectAFlow Pumps
  • Modelo / Serial
    Model Numbers:  CB004, CB005, CB006, CB6004, CB6007, P100X2-14, P200X2-14, P270X1-7, P400X2-14, P400X1-7+5/60, P400X2-14+5/30, P600X2-14, P600X1-7D, and SAF01.   Part Numbers: 5001481,5001521,5001651,5001771,5001780,5001788,5001799, 5001807,5001808,5001809,5001810,5001811,5001830, and 5001831.   Specific lot numbers: 122215, 132435, 132464, 932165, and 962434. Also, all lot numbers that begin with:  98 (except 982631 and 982645),   99,   9A (except 9A2913),   9B,   9C,   01, 02, 03, 04, 05, 06, 07, 08, 09,   0A,   0B,   and 0C (except 0C2949 and 0C2950).
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide (USA) Distribution and worldwide to: Australia, Canada, Cyprus, Italy, Germany, Finland, Greece, Israel, South Africa, Sweden, UAE, and UK.
  • Descripción del producto
    I-Flow ON-Q with Select-A-Flow Pumps, || Intended for continuous and/or intermittent delivery of medication to and around surgical wound sites and/or close proximity to nerves for preoperative, perioperative and postoperative regional anesthesia and pain management. || It is a controller that allows the user to regulate the amount of medication that is dispensed.
  • Manufacturer
    I-Flow Corporation

Manufacturer

I-Flow Corporation
  • Dirección del fabricante
    I-Flow Corporation, 20202 Windrow Dr, Lake Forest CA 92630-8152
  • Source
    USFDA