BEUDAMED
    FDA Recall Terminated

    KCI RotoProne Critical Care Therapy System buckles for securing patient to the surface during proning therapy, Model 209500. Indicated for treatment and prevention of pulmonary complications.

    Recall: Z-2182-2011 · Initiated February 18, 2011

    Recall

    Recall Number
    Z-2182-2011
    Event Number
    58466
    Firm
    KCI USA, Inc.
    FEI Number
    1625774
    Product Code
    IKZ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    February 18, 2011
    Posted
    May 10, 2011
    Terminated
    October 24, 2011
    Address
    4958 Stout Dr, San Antonio, TX, 78219-4334

    Description

    KCI RotoProne Critical Care Therapy System buckles for securing patient to the surface during proning therapy, Model 209500. Indicated for treatment and prevention of pulmonary complications.

    Reason

    Buckles used to secure patient to surface during proning therapy can come open if not properly engaged by user.

    Action

    Firm sent a letter with the "Warning: Improper Insertion of the RotoProne Therapy System Buckle Can Lead To Unintentional Bed Exit" to all consignees on 2/23/2011. The letter identified the affected product and the reason for the recall. Customers were instructed to read the attached product warning regarding the proper method to attach the RotoProne buckles and to post it with the device to ensure continued proper use of the buckles. If customers had questions regarding the proper use of the buckles, they were to contact KCI Customer Technical Service at 1-800-275-4524.

    Distribution

    Worldwide Distribution - USA and Kuwait.

    Quantity

    229 units