BEUDAMED
    FDA Recall Terminated

    CLINITRON CII Air Fluidized Therapy Units. Intended to prevent and/or treat pressure ulcer development and wound deterioration in patients who have a significant risk of developing these problems and who generally also have one or more of the following conditions: immobility, poor nutrition, diminished level of consciousness, reduced subcutaneous tissue or multi-system failure.

    Recall: Z-1902-2009 · Initiated June 24, 2009

    Recall

    Recall Number
    Z-1902-2009
    Event Number
    52524
    Firm
    Hill-Rom Manufacturing, Inc.
    FEI Number
    1045510
    Product Code
    INX
    Status
    Terminated
    Root Cause
    Equipment maintenance
    Initiated
    June 24, 2009
    Posted
    August 25, 2009
    Terminated
    July 11, 2012
    Address
    4349 Corporate Rd, Charleston, SC, 29405-7445

    Description

    CLINITRON CII Air Fluidized Therapy Units. Intended to prevent and/or treat pressure ulcer development and wound deterioration in patients who have a significant risk of developing these problems and who generally also have one or more of the following conditions: immobility, poor nutrition, diminished level of consciousness, reduced subcutaneous tissue or multi-system failure.

    Reason

    Incorrectly repaired power cord wires can potentially overheat resulting in smoldering sound foam in the base of the therapy bed.

    Action

    Hill-Rom issued an "Urgent Field Safety Notice" letter dated February 2, 2009 addressed to Facility Risk Managers and Facility Administrators. The notice detailed the issue and instructed users on actions to be taken. For further information, please contact Hill-Rom Customer Service at 1-800-638-2546.

    Distribution

    Worldwide Distribution -- United States, Abu Dhabi, Brazil, Canada, Chile, Columbia, Mexico, Newfoundland, Puerto Rico, Saudi Arabia, Singapore, Taiwan, Turkey and Venezuela.

    Quantity

    625 units (total both units)