BEUDAMED
    FDA Recall Terminated

    RotoRest Delta Kinetic Therapy System INDICATIONS: Treatment and prevention of pulmonary complications as a result of immobility, Thoracic or lumbar fracture, Cervical traction, Skeletal traction

    Recall: Z-0409-2013 · Initiated June 27, 2012

    Recall

    Recall Number
    Z-0409-2013
    Event Number
    62805
    Firm
    KCI USA, Inc.
    FEI Number
    1625774
    Product Code
    IOQ
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    June 27, 2012
    Posted
    November 20, 2012
    Terminated
    April 22, 2013
    Address
    4958 Stout Dr, San Antonio, TX, 78219-4334

    Description

    RotoRest Delta Kinetic Therapy System INDICATIONS: Treatment and prevention of pulmonary complications as a result of immobility, Thoracic or lumbar fracture, Cervical traction, Skeletal traction

    Reason

    The firm is initiating a voluntary medical device correction for the RotoRest Delta Therapy System head pack. KCI has received complaints alleging patients experiencing skin breakdown on the head and face due to the positioning of the head pack. In a few instances, the patient received injuries ranging from Stage III to Stage IV pressure ulcers.

    Action

    KCI sent an Urgent - Voluntary Medical Device Correction letter dated June 27, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed that KCI would contact them soon to coorinate a shipment of a replacement of the affected product. For any questions customers were instructed to call 1-800-275-4524, Selection Option 3 followed by Option 2. For questions regarding this recall call 1-800-275-4524.

    Distribution

    Nationwide Distribution including AL, CA, CO, OK and GA.

    Quantity

    282 units