BEUDAMED
    FDA Recall Terminated

    Flexicair II (Model number 13000) Low Airloss Therapy Units For use to prevent pressure sore development and wound deterioration in patients who have significant risk of developing these problems and who generally also have one or more to the following conditions: immobility, incontinence, poor nutrition, diminished level of consciousness, reduced subcutaneous tissue, or multi-system failure.

    Recall: Z-1253-2011 · Initiated December 6, 2010

    Recall

    Recall Number
    Z-1253-2011
    Event Number
    57592
    Firm
    Hill-Rom Manufacturing, Inc.
    FEI Number
    1045510
    Product Code
    IOQ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 6, 2010
    Posted
    February 15, 2011
    Terminated
    November 1, 2011
    Address
    4349 Corporate Rd, Charleston, SC, 29405-7445

    Description

    Flexicair II (Model number 13000) Low Airloss Therapy Units For use to prevent pressure sore development and wound deterioration in patients who have significant risk of developing these problems and who generally also have one or more to the following conditions: immobility, incontinence, poor nutrition, diminished level of consciousness, reduced subcutaneous tissue, or multi-system failure.

    Reason

    Due to product age and parts availability the units are being withdrawn to reduce a potential health risk to patients when bed rails are not used.

    Action

    Hill-Rom Manufacturing, Inc. sent an Urgent Medical Device Withdrawal letter dated December 15, 2010, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. The FLEXICAR MC3 AND FLEXICAIR 13000 were no longer available for rental as of November 15, 2010. Customers in Michigan were required to switch to another product by December 31, 2010. All other customers were required to switch to another product by March 4, 2011. Customers advised to continue the use of the product until arrangements could be made to replace the product. were notified by letter on/about 12/06/2010. The letter indicated the units will no longer be available for rental as of 11/15/2010. Patients in Michigan currently using the products will be required to switch to another product by 12/31/2010. All other patients using the products will be required to switch to another product by 03/04/2010. They were advised that a Hill-Rom representative will be contacted them to discuss details of the product withdrawal and possible alternative surfaces for their patients. For questions regarding this recall call 800-445-3720.

    Distribution

    Nationwide Distribution including CA, FL, GA, IL, MI , MS, NJ, NY, OH and PA

    Quantity

    1 Flexicair II unit