SlingBar Wide 670. Designed to meet the needs for lifting humans.
FDA Recall Z-1475-2013 · Posted 2013-06-05
Recalling FirmHill-Rom, Inc.
Recall StatusTerminated
Product CodeFSA
Date Initiated2013-04-30
Date Terminated2014-11-28
Product Quantity412
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.
Firm 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.
Root Cause
Device Design
Distribution Pattern
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.