Events

Retiro De Equipo (Recall) de Device Recall CalMed SU12202

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 California Medical Laboratories 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
    63896
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0649-2013
  • Fecha de inicio del evento
    2012-11-02
  • Fecha de publicación del evento
    2013-01-07
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-03-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114967
  • 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
    Sucker, cardiotomy return, cardiopulmonary bypass - Product Code DTS
  • Causa
    California medical laboratories, inc. has identified an issue with the rigid tip suction wand. due to insufficient adhesive application, the distal tip has the potential to come loose from the wand and fall into the patient's chest cavity.
  • Acción
    CalMed sent an Urgent Field Safety Notice dated November 2, 2012, to all affected customers by certified mail and additionally followed up via electronic mail. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to contact Sorin Group USA's Customers Service Department at +1-800-650-2623 to return any unused product and order replacements. Customers were also asked to communicate the important safety information to all potential users within their organization or any other organization where the affected product may have been transferred and to maintain awareness of this communication for an appropriate period of time to ensure effectiveness of the corrective action. Customers were asked to return all unused product to CalMed Labs. Customers with questions were instructed to contact California Medical Laboratories at +1-714-556-7365. For questions regarding this recall call 714-556-7365.

Device

Device Recall CalMed SU12202
  • Modelo / Serial
    Catalog No: SU-12202 Lot No: S112462, S111480
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including AZ, FL, CA, LA, CO, and MS. Internationally to Canada, Israel, Greece, Hong Kong, India, Ireland, Jordan, Lebanon, Malaysia, Netherlands, Russia, Saudi Arabia, South Africa and Spain.
  • Descripción del producto
    Sterile Rigid Tip Suction Wand || The Suction Wands are indicated for use to remove excess fluid from the surgical field.
  • Manufacturer
    California Medical Laboratories Inc

Manufacturer

California Medical Laboratories Inc
  • Dirección del fabricante
    California Medical Laboratories Inc, 1570 Sunland Ln, Costa Mesa CA 92626-1515
  • Source
    USFDA