FDA-Device2013-06-12Class II
SlingBar Standard. Designed to meet the needs for lifting humans.
Hill-Rom, Inc.
Hazard
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.
Sold states
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.
Affected count
726
Manufactured in
1069 State Route 46 East, N/A, Batesville, IN, United States
Products
SlingBar Standard. Designed to meet the needs for lifting humans.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1476-2013Don't want to check this manually?
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