SlingBar Standard. Designed to meet the needs for lifting humans.
This recall has been terminated (originally issued June 5, 2013).
- Company
- Hill-Rom, Inc.
- Recall Initiated
- April 30, 2013
- Posted
- June 5, 2013
- Terminated
- November 28, 2014
- Recall Number
- Z-1476-2013
- Quantity
- 726
- Firm Location
- Batesville, IN
- Official Source
- View on FDA website ↗
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.
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.
Lot / Code Info
Product #3156011
Root Cause
Device Design
Action Taken
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.