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U.S. Department of Health and Human Services

Class 2 Device Recall SlingBar 670

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 Class 2 Recall
SlingBar 670
see related information
Date Posted June 05, 2013
Recall Status1 Open
Recall Number Z-1475-2013
Recall Event ID 64550
Product Classification Lift, Patient, Non-Ac-Powered - Product Code FSA
Product SlingBar Wide 670. Designed to meet the needs for lifting humans.
Code Information Product # 3156012, 3156017
Recalling Firm/
Manufacturer
Hill-Rom, Inc.
1069 State Route 46 East
Batesville, Indiana 47006-7520
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
DESIGN: Device 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.
Quantity in Commerce 412
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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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