BEUDAMED
    FDA Recall Terminated

    Generation 4 electronic liquid gauges used on the Caire Liberator, Stroller, Sprint, and Hi-Flow Portable oxygen unit.

    Recall: Z-1716-2008 · Initiated October 23, 2007

    Recall

    Recall Number
    Z-1716-2008
    Event Number
    47468
    Firm
    Caire, Inc.
    FEI Number
    3004972304
    Product Code
    BYJ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 23, 2007
    Posted
    August 26, 2008
    Terminated
    December 17, 2009
    Address
    1800 Sandy Plains Pkwy, Ste 316, Marietta, GA, 30066-6363

    Description

    Generation 4 electronic liquid gauges used on the Caire Liberator, Stroller, Sprint, and Hi-Flow Portable oxygen unit.

    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.

    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.

    Quantity

    3470