Events

Rappel de Device Recall STATCheck

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Ventlab LLC.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    73766
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1880-2016
  • Date de mise en oeuvre de l'événement
    2016-03-15
  • Date de publication de l'événement
    2016-06-01
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-11-01
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144926
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Analyzer, gas, carbon-dioxide, gaseous-phase - Product Code CCK
  • Cause
    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.
  • Action
    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
  • Modèle / numéro de série
    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
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide distribution to AZ, MS, NY, MO, FL, WI, TX, FL, and CA.
  • Description du dispositif
    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
  • Adresse du fabricant
    Ventlab LLC, 2710 Northridge Dr NW Ste A, Grand Rapids MI 49544-9112
  • Société-mère du fabricant (2017)
    Ventlab Llc
  • Source
    USFDA