BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-1476-2013 · Reported June 12, 2013

    Enforcement

    Recall Number
    Z-1476-2013
    Event ID
    64550
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Hill-Rom, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 12, 2013
    Initiation Date
    April 30, 2013
    Classification Date
    June 5, 2013
    Termination Date
    November 28, 2014
    Address
    1069 State Route 46 East, N/A, Batesville, IN, 47006-7520, United States

    Description

    SlingBar Standard. 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.

    Code Info

    Product #3156011

    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

    726