BEUDAMED
    FDA Recall Terminated

    Li-Ion battery used in the Oxus Portable Oxygen Concentrator (POC), RS-00400. Also branded as Reliability Plus byDrive. The Portable Oxygen Concentrator is intended to deliver concentrated oxygen for adult patients with chronic pulmonary diseases.

    Recall: Z-0768-2013 · Initiated January 14, 2013

    Recall

    Recall Number
    Z-0768-2013
    Event Number
    64057
    Firm
    Oxus America, Inc.
    FEI Number
    3008841036
    Product Code
    CAW
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    January 14, 2013
    Posted
    February 2, 2013
    Terminated
    July 17, 2013
    Address
    1685 Northfield Dr, Rochester Hills, MI, 48309-3825

    Description

    Li-Ion battery used in the Oxus Portable Oxygen Concentrator (POC), RS-00400. Also branded as Reliability Plus byDrive. The Portable Oxygen Concentrator is intended to deliver concentrated oxygen for adult patients with chronic pulmonary diseases.

    Reason

    Due to past battery inventory storage conditions and deficiencies in the maintenance procedure, it was possible that some batteries were over-discharged to point of damaging the cells.

    Action

    Oxus, Inc. sent an "URGENT: MEDICAL DEVICE RECALL" letter dated January 11, 2013 to all affected customers.The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at 1-888-475-1568 for information related to this recall.

    Distribution

    Worldwide Distribution-USA including the states of New York, Michigan, Colorado, Texas, Iowa, Florida, Georgia, Ohio, Wisconsin, Oregon, Alabama, Illinois, Utah, Oklahoma, West Virginia and California and the countries of Canada, European Union, South Africa, Korea and Brazil.

    Quantity

    1724 total units