Events

Recall of Caire Generation 4 electronic liquid level gauge

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Caire, 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
    47468
  • Event Risk Class
    Class 2
  • Event Number
    Z-1716-2008
  • Event Initiated Date
    2007-10-23
  • Event Date Posted
    2008-08-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-12-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69542
  • 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
    Electronic liquid level guage - Product Code BYJ
  • Reason
    Moisture ingress into the electronic liquid level indicator may cause inaccurate liquid oxygen level readings. the oxygen could run out without the patient knowledge.
  • Action
    A Technical Service Bulletin was sent to consignees on/about October 23, 2007 to notify customers of the potential issue. Technical support and information for ordering replacement Generation 4 liquid gauges were offered. For technical concerns or if you have not received the notification from the firm, contact U.S. Technical Service at 1-800-482-2473 or European Technical Service at +44 (0) 797 1260077.

Device

Caire Generation 4 electronic liquid level gauge
  • Model / Serial
    Liberator Base units - CBB300634XXXX - CBB300738XXXX. Includes units produced from week 34-2006 through week 38-2007.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    U.S. Nationwide and the following foreign countries: Argentina, Austria, Brazil, Canada, China, Chile, Central America/Caribbean, Colombia, Costa Rica, Europe, Austria, Belgium, Denmark, France, Germany, Greece, Hungary, Irish Republic, Italy, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, United Kingdom, Mexico, South America, Peru and Uruguay.
  • Product Description
    Generation 4 electronic liquid gauges used on the Caire Liberator, Stroller, Sprint, and Hi-Flow Portable oxygen unit.
  • Manufacturer
    Caire, Inc.

Manufacturer

Caire, Inc.
  • Manufacturer Address
    Caire, Inc., 1800 Sandy Plains Pkwy Ste 316, Marietta GA 30066-6363
  • Source
    USFDA