BEUDAMED
    FDA Recall Terminated

    Clinitron At Home Air Fluidized Therapy Unit

    Recall: Z-0057-04 · Initiated January 14, 2002

    Recall

    Recall Number
    Z-0057-04
    Event Number
    27190
    Firm
    Hill-Rom Manufacturing, Inc.
    FEI Number
    1045510
    Product Code
    INX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 14, 2002
    Posted
    October 24, 2003
    Terminated
    October 27, 2003
    Address
    4349 Corporate Road, Charleston, SC, 29405

    Description

    Clinitron At Home Air Fluidized Therapy Unit

    Reason

    Power cord overheating

    Action

    Consignees were notified by letter sent January 14, 2002 warning them of the hazard involved with the defective part. They were informed that Hill Rom needed to replace the power cord on each unit to correct the possibility of the power cord from overheating, melting or smoking. The maintenance would be performed at the location of each unit (most of which are at their rental facilities located nationwide) by the firm''s servicing representatives. Meanwhile, customers were urged to check the power cord to ensure that it is fully inserted into the wall outlet and the connector on the Clinitron At Home Air Fluidized Therapy Unit. The modification was to be completed by August 31, 2002.

    Distribution

    Hill Rom primarily leases these units to home care patients and some are sold nationwide.

    Quantity

    1703 units