Liko Standard Slingbar 450. The Standard Slingbar 450 is a versatile sling bar which can be used for most lifting situat

FDA device recall Z-0622-2013 · posted 2012-12-31 · Terminated

Recall details

Recalling firm

Hill-Rom, Inc.

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

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

FSA

Quantity affected

261 units

Distribution

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

Date initiated

2012-12-06

Date posted

2012-12-31

Date terminated

2014-11-06

Location

Batesville, IN