BEUDAMED
    FDA Recall Terminated

    SlingBar 360. Designed to meet the needs for lifting humans.

    Recall: Z-1474-2013 · Initiated April 30, 2013

    Recall

    Recall Number
    Z-1474-2013
    Event Number
    64550
    Firm
    Hill-Rom, Inc.
    FEI Number
    1824206
    Product Code
    FSA
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    April 30, 2013
    Posted
    June 5, 2013
    Terminated
    November 28, 2014
    Address
    1069 State Route 46 East, Batesville, IN, 47006-7520

    Description

    SlingBar 360. Designed to meet the needs for lifting humans.

    Reason

    Retrospective review found 4 sling bars that may present a potential for impalement if a patient, caregiver or bystander were to fall onto the hooks based on a simulated test method. In effort to eliminate any risk of injury, Hill-Rom is requesting products be removed from field use and replaced with an updated design.

    Action

    On 4/30/13 an URGENT MEDICAL DEVICE RECALL CORRECTION was issued to all consignees detailing the hazards and actions that are needed. Included with this notification is a Response Form/Receipt and a Replacement Guide, complete and return the form to Hill-Rom as soon as possible. Hill-Rom will send you the applicable number of sling bars to you at no cost. After you receive the new sling bars, we request that you discard the old ones.

    Distribution

    Worldwide Distribution-USA (nationwide) including the states of AZ, CA, CO, FL, IL, IN, KS, LA, MA, MI, MN, MO, NC, NH, NJ, NV, OH, OK, PA, SC, TN, UT, WA, and WI, and the countries of Canada, Australia, Austria, Belgium, Switzerland, Germany Denmark, Spain, Finland, France, United Kingdom, Greece, Hong Kong, Ireland, Israel, Italy, Japan, Netherlands, Norway, New Zealand, Portugal, Sweden, and Turkey.

    Quantity

    16