BEUDAMED
    FDA Recall Terminated

    Cobham AMOGS Advanced Medical Oxygen Generating System, 70309-03900-101. Concentrator, Oxygen, Molecular Sieve, S/A P/N: 70309-03900-101, Mfg P/N 3261165-0101. The firm name on the label is Carleton Life Support Systems Inc., Davenport, IA.

    Recall: Z-2009-2009 · Initiated July 24, 2009

    Recall

    Recall Number
    Z-2009-2009
    Event Number
    52766
    Firm
    Carleton Life Support Systems Inc
    FEI Number
    3002840531
    Product Code
    CAW
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    July 24, 2009
    Posted
    September 16, 2009
    Terminated
    March 22, 2012
    Address
    2734 Hickory Grove Rd, Davenport, IA, 52804-1203

    Description

    Cobham AMOGS Advanced Medical Oxygen Generating System, 70309-03900-101. Concentrator, Oxygen, Molecular Sieve, S/A P/N: 70309-03900-101, Mfg P/N 3261165-0101. The firm name on the label is Carleton Life Support Systems Inc., Davenport, IA.

    Reason

    The backup oxygen supply control valve on the oxygen concentrator could fail resulting in it sticking in the open or closed positions.

    Action

    Cobham Life Support Systems, Inc. issued letters to their two customers via e-mail. One customer letter was dated July 24, 2009 and the other was dated July 28, 2009. Both letters notified the customer of the reason for the recall and that the usage of the concentrator must be restricted to exclude actual use with a patient until corrected. The letter informs customers they are redesigning the backup supply control valve and will coordinate the retrofit in the future. For further information, contact Cobham Life Support at 1-563-383-6421.

    Distribution

    Nationwide Distribution -- CT and AL.

    Quantity

    23 units