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U.S. Department of Health and Human Services

Class 2 Device Recall SlingBar Standard

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  Class 2 Device Recall SlingBar Standard see related information
Date Initiated by Firm April 30, 2013
Date Posted June 05, 2013
Recall Status1 Terminated 3 on November 28, 2014
Recall Number Z-1476-2013
Recall Event ID 64550
Product Classification Lift, patient, non-ac-powered - Product Code FSA
Product SlingBar Standard.

Designed to meet the needs for lifting humans.
Code Information Product #3156011
Recalling Firm/
Manufacturer		 Hill-Rom, Inc.
1069 State Route 46 East
Batesville IN 47006-7520
For Additional Information Contact
812-934-7777
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		 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 726
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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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