Events

Retiro De Equipo (Recall) de Device Recall StatCheck Resuscitator

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 Ventlab 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
    63347
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-0172-2013
  • Fecha de inicio del evento
    2012-07-11
  • Fecha de publicación del evento
    2012-11-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-06-30
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=113549
  • 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
    Ventilator, emergency, manual (resuscitator) - Product Code BTM
  • Causa
    Possible volume leakage through the inlet valve during compressions of the resuscitator bag.
  • Acción
    VentLab Corporation sent an Attention: Recall Notification letter dated July 10, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory for the affected product, complete and return the enclosed response form by fax to 336-753-5002, indicating whether or not their facility has any of the affected product. Customers can also scan and email the response form to CSR@Ventlab.com. For questions regarding this recall call 336-753-5000.

Device

Device Recall StatCheck Resuscitator
  • Modelo / Serial
    Product List 071012, Product Codes: SC9001C, Lot #101360, 101751, 101819, 101948, 102090, 102164 and SC9001C-C, Lot #101100, 101441, 101780, 102193.
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including IL, OH, NY and TN.
  • Descripción del producto
    Stat-Check Resuscitator, Adult Manual Emergency Resuscitator with A.C.E. /Stat-Check CO2 Indicator, SC 9000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. || The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.
  • Manufacturer
    Ventlab Corporation

Manufacturer

Ventlab Corporation
  • Dirección del fabricante
    Ventlab Corporation, 155 Boyce Dr, Mocksville NC 27028-4187
  • Source
    USFDA