Events

Recall of Device Recall Vital Signs Breathing Circuits

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Vital Signs Colorado Inc..

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
    67164
  • Event Risk Class
    Class 2
  • Event Number
    Z-0812-2014
  • Event Initiated Date
    2013-12-26
  • Event Date Posted
    2014-01-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-07-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124805
  • 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
    Filter, bacterial, breathing-circuit - Product Code CAH
  • Reason
    A circuit in use was occluded by a blue port cap that was inadvertently attached to the circuit as a result of an internal inspection error and will cause occlusion of gas flow.
  • Action
    GE Healthcare sent an Urgent Medical Device Correction letter on December 12, 2013 to all affected customers via certified letter to follow the safety instructions to: 1) Please follow all safety instructions in accordance with the instructions for use (IFU). 2) During installation, visually inspect the Vital Signs Breathing Circuits for any plugged ports. If 15mm or 22mm blue port caps are attached to any ports, please remove and discard. 3) Prior to use, the circuits should be pressure tested for leaks and flow tested for obstructions in accordance with the ventilator manufacturers specifications. The long-term solution is to update the instructions for the assembly operator and modify the circuit air test process by replacing the cap with a plug tethered to the workstation so the plug cannot be left on the circuit. If you have any questions or concerns regarding this notification, please contact GEMSIT Customer Service at +1-800-588-7044 (Domestic) or Vital Signs Customer Service at +1-800-932-0760 (International). Hours of Operation: 8:00 am EST to 6:00 pm EST. Please be assured that maintaining a high level of safety and quality is our highest priority. If you have any questions, please contact us immediately per the contact information above.

Device

Device Recall Vital Signs Breathing Circuits
  • Model / Serial
    PartNumber : 4S78XX00,155512,155518,156505,156545,1576162,1576214,542011,542021,542031,1553196,1572347,1553402,156205,156310,1574701,1574710,1574711,1574712,1574723,1572414,A4JXXXXX,6463,C311123X,C6X1XX1X,207002,C316123X,1560023,201814,1730327,20CF800C,C116123X,1570103,20CT8050,1577112,1552016,A4JXOXXX,CXX61X2X,1552017,1552018,20CT8048,20CT8055,M1171508,M1181639,1552020,M1162025,155200EU,1552017CN,1574792,M1171508VS,M1181639VS,1552026,1552027,1552028,
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) including Puerto Rico; and Internationally to: Belgium, Canada, Chile, Mexico, Costa Rica, Kuwait, United Kingdom, Greece, Czech Republic, Latvia, Turkey, China, France, Italy, Brazil, Korea, Germany, Thailand, Egypt, Austria, Dominican Republic, India, Israel, Colombia, Japan, Netherlands, Venezula, Saudi Arabia, Argentina, Malaysia, Sweden, Lebanon, South Korea, Finland, United Arab Emirates, Taiwan, Panama, Uruguay, Singapore, Hong Kong, Ecuador, Peru, Oman, Spain, Lithuania, and South Africa.
  • Product Description
    Vital Signs Anesthesia Circuits || The Ventilator Circuit is intended for use as an interface between a ventilator dependent patient and a ventilator. The Anesthesia Circuit is intended to administer medical gases to a patient during anesthesia. The CPAP Circuit is intended to increase the airway pressure of a patient.
  • Manufacturer
    Vital Signs Colorado Inc.

Manufacturer

Vital Signs Colorado Inc.
  • Manufacturer Address
    Vital Signs Colorado Inc., 11039 East Lansing Circle, Englewood CO 80112-5909
  • Source
    USFDA