BEUDAMED
    FDA Recall Terminated

    CLINITRON CII Air Fluidized Therapy unit.

    Recall: Z-0989-03 · Initiated May 5, 2003

    Recall

    Recall Number
    Z-0989-03
    Event Number
    26486
    Firm
    Hill-Rom Manufacturing, Inc.
    FEI Number
    1045510
    Product Code
    INX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 5, 2003
    Posted
    July 10, 2003
    Terminated
    July 26, 2004
    Address
    4349 Corporate Road, Charleston, SC, 29405

    Description

    CLINITRON CII Air Fluidized Therapy unit.

    Reason

    Malfunction of side-rail latching pin coupled with inadequate directions for use.

    Action

    Consignees were notified by letter sent via Airborne express, on May 5, 2003. Side-rail latching pins will be replaced with a more robust version. Label indicating directions for use will be modified to include detailed information on proper procedures for moving the units.

    Distribution

    The units are primarily leased to hospitals. Units have been sold to hospitals located nationwide and to Canada, Austria, France, Germany Ireland Italy, Netherlands, Spain, Sweden, Switzerland and the United Kingdom.

    Quantity

    122 units (including both units)