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 Corporation.

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
    28689
  • Event Risk Class
    Class 2
  • Event Number
    Z-0893-04
  • Event Initiated Date
    2004-03-26
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-07-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=32358
  • 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
    Ventilator, Emergency, Manual (Resuscitator) - Product Code BTM
  • Reason
    In some cases the device may develop small cracks that could expand over time and result in reduced shelf life or other failure.
  • Action
    Consignees were notified by letter on 3/26/2004.

Device

Device Recall STATCheck
  • Model / Serial
    Model #SC200, Lot #3254-03, 4020-01, 4040-09, 4043-05, 4056-05, 4063-07, 4064-20, 4078-03
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    CA
  • Product Description
    A.C.E. STAT-Check CO¿ Indicator, Single, Single Patient Use, Non-Sterile, Rx only, Latex Free, Re-Order# SC200, Resuscitation ACE Corp., 155 Boyce Drive, Mocksville, NC 27028
  • Manufacturer
    Ventlab Corporation

Manufacturer

Ventlab Corporation
  • Manufacturer Address
    Ventlab Corporation, 155 Boyce Dr, Mocksville NC 27028
  • Source
    USFDA