Recall StatusTerminated
Date Initiated2012-12-06
Date Terminated2014-11-06
Product Quantity261 units
Reason for Recall
Liko/Hill-Rom has received reports from facilities which indicate that serious injuries have been received related to the Standard Sling bar 450. There have been 6 complaints of injury related to the product over the past 32 years (6 out of 838,687,856 estimated patient uses). One of the injuries was associated with a patient during use, four injuries occurred when the slingbar was not in use wher
Firm Action
Hill-rom sent an URGENT MEDICAL DEVICE RECALL notification letter dated December 6, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer..
Customers were requested to please read, fill in completely, and return the Response Form to Hill-Rom immediately. This information will be compiled and reported to the applicable regulatory governing bodies. If we do not receive your response we will be required to contact you asking for your response.
Continue to follow safe lifting practices, and do not allow unauthorized persons, especially children, to play around or operate the lift.
If you have any questions concerning this Customer Safety Notification, please contact Hill-Rom Technical Support at 800-445-3720.
Distribution Pattern
Worldwide Distribution -- US (nationwide) including the states of AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, MA, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OK, OR, PA, TN, TX, UT, WA, WV, and WY., and the country Canada,
We have not yet defined our European or International facilities at this time.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.