Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2319-2008

Universal SlingBar 450 with Quick-release Hook Product Number: 3156085 Used in combination with all lifts...

Liko AB / initiated 2008-07-01 / Terminated / root cause: design

Liko AB began a recall of Universal SlingBar 450 with Quick-release Hook Product Number: 3156085 Used in combination with all lifts from Liko, i.e. mobile lifts and overhead lifts on . The reason FDA records is "A component securing the Universal SlingBar to the patient lift, may experience a nut unthreading resulting in the sling bar detaching from the lift causing the patient to fall". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-2319-2008
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Liko AB
Product
Universal SlingBar 450 with Quick-release Hook Product Number: 3156085 Used in combination with all lifts from Liko, i.e. mobile lifts and overhead lifts
Product code
FSA Lift, Patient, Non-Ac-Powered
Reason for recall
A component securing the Universal SlingBar to the patient lift, may experience a nut unthreading resulting in the sling bar detaching from the lift causing the patient to fall.
Root cause tag
design
FDA root cause
Component design/selection
Action
Liko North America ,the US Distributor, notified accounts by letter dated June 30, 2008 and provided a Field Safety Notice with Safety Inspection Procedures to performed on the lift prior to use. Replacement slingbars are being provided. If you have questions, contact the Liko product distributor in your country. Contact information can be found at www.liko.com/int/distributors.asp.
Distribution
Nationwide
Product codes and lots
Affected serial numbers on sling bars: 1200101-1245680, 121204-121499, and 12222407-12225241