Events

Recall of Device Recall STATCheck

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ventlab LLC.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    73766
  • Event Risk Class
    Class 2
  • Event Number
    Z-1880-2016
  • Event Initiated Date
    2016-03-15
  • Event Date Posted
    2016-06-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-11-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144926
  • Notes / Alerts
    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.
  • Extra notes in the data
    Analyzer, gas, carbon-dioxide, gaseous-phase - Product Code CCK
  • Reason
    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
  • Model / 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
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution to AZ, MS, NY, MO, FL, WI, TX, FL, and CA.
  • Product Description
    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
  • Manufacturer Address
    Ventlab LLC, 2710 Northridge Dr NW Ste A, Grand Rapids MI 49544-9112
  • Manufacturer Parent Company (2017)
    Ventlab Llc
  • Source
    USFDA