Events

Retiro De Equipo (Recall) de Device Recall STATCheck

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 LLC.

¿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
    73766
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1880-2016
  • Fecha de inicio del evento
    2016-03-15
  • Fecha de publicación del evento
    2016-06-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-11-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144926
  • 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
    Analyzer, gas, carbon-dioxide, gaseous-phase - Product Code CCK
  • Causa
    Stat-check co2 indicators are non-functional. the indicator is yellow when not in use and should be purple when not in use. the yellow indicates a 5% co2 level, cardiac massage and ventiliation being performed correctly. the color will not change during use and will not be an indicator of co2 level or improper performance of cardiac message and ventilation.
  • Acción
    Ventlab sent an URGENT: MEDICAL DEVICE PRODUCT REMOVAL notification dated March 14, 2016, on March 15, 2016, electronically to all affected customers. Customers were instructed to return the affected product and notify affected consignees of the recall. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. If you have any questions regarding this action, please call Ventlab at 1-844-635-5326, or email at PFA@ventlab.com.

Device

Device Recall STATCheck
  • Modelo / Serial
    Model SC9001B Adult STAT-Check Resuscitation Bag w/ Inflatable Bag Reservoir & Mask Lot numbers 303320 and 303612  Model SC9001C Adult STAT-Check Resuscitation Bag w/ Corrugate Tube Reservoir & Mask Lot number 303400  Model SC9001C-C Adult STAT-Check Resuscitation Bag w/ Corrugate Tube Reservoir, Mask & Straight Connector Lot numbers 303523 and 303791  Model SC8001B Pediatric STAT-Check Resuscitation Bag w/ Inflatable Bag Reservoir & Mask Lot number 303833
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution to AZ, MS, NY, MO, FL, WI, TX, FL, and CA.
  • Descripción del producto
    STAT-Check Resuscitation Bag || Manual Emergency Resuscitation Bag with Carbon dioxide gas analyzer || Intended for use in various clinical situations to provide respiratory support in the presence of reversible apnea commonly associated with respiratory arrest. The device should only be used by personnel trained in CPR procedures. The ACE/STAT-Check II is intended for use as an adjunct assessment tool for verification of successful ventilation / intubation in patients > 2.2 kilograms (5lbs.).
  • Manufacturer
    Ventlab LLC

Manufacturer

Ventlab LLC
  • Dirección del fabricante
    Ventlab LLC, 2710 Northridge Dr NW Ste A, Grand Rapids MI 49544-9112
  • Empresa matriz del fabricante (2017)
    Ventlab Llc
  • Source
    USFDA