Liko Universal SlingBars Universal SlingBar" 350, Universal SlingBar" 350 QRH, Universal SlingBar" 350 R2R, Universal Sl

FDA device recall Z-1916-2016 · posted 2016-06-07 · Terminated

Recall details

Recalling firm

Hill-Rom, Inc.

Reason for recall

The center bolt of the sling bar, which connects the bar to the patient lift, has failed during use. If the sling bar is not used as intended the bolt may be weakened. If the bolt is weakened there is a potential risk for breakage with the result of a free fall of the patient. This hazard could cause potentially minor to catastrophic injuries to a patient.

Action taken

On 3/8/2016, MEDICAL DEVICE CORRECTION notifications were sent to the affected US customers via email and courier. On 3/24/2016, MEDICAL DEVICE CORRECTION notifications were sent to the affected Canadian customers via email and courier. On 3/29/2016, MEDICAL DEVICE CORRECTION notifications were sent to the affected Global customers via email and Docapost. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. The notification provided new instructions for users with a lift manufactured prior to 11/19/2013, instructed the user on how to inspect for damage, and offers replacement at a 50% reduction in cost. If you have any questions concerning this Field Safety Notice, please contact Hill-Rom Technical Support, your distributor, or your Hill-Rom representative.

Root cause

Labeling design

Status

Terminated

Product code

FSA

Quantity affected

163,561

Distribution

Worldwide and US Nationwide Distribution AE, AO, AR , AT , AU , AZ , BD , BE , BG , BH , BM , BN , BR , CA , CH , CL , CN , CO , CS , CZ , DE , DK , EG , ES , FI , FR , GB , GR , HK , HR , HU , ID , I

Date initiated

2016-03-08

Date posted

2016-06-07

Date terminated

2017-05-15

Location

Batesville, IN