Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1396-2011

Liko Comfort Sling Plus Model 300, Part number 35300305, Size Medium, LIKO, Sweden. Liko a Hill-Rom Company...

Hill-Rom Inc. / initiated 2011-02-09 / Terminated

Hill-Rom, Inc. began a recall of Liko Comfort Sling Plus Model 300, Part number 35300305, Size Medium, LIKO, Sweden. Liko a Hill-Rom Company. Enables a comfortable sitting position and adapts... on . The reason FDA records is "Slings were improperly assembled and the loops that are used to support the sling when hung from a lift were too long, potentially putting the patient being lifted at risk of falling out". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-1396-2011
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Hill-Rom Inc.
Product
Liko Comfort Sling Plus Model 300, Part number 35300305, Size Medium, LIKO, Sweden. Liko a Hill-Rom Company. Enables a comfortable sitting position and adapts to the patient without the need for individual adjustments when transferring a patient with a lift.
Product code
FSA Lift, Patient, Non-Ac-Powered
Reason for recall
Slings were improperly assembled and the loops that are used to support the sling when hung from a lift were too long, potentially putting the patient being lifted at risk of falling out.
FDA root cause
Pending
Action
The firm sent an URGENT MEDICAL DEVICE RECALL notice dated 02/09/2011 to Facility Risk Manager/Facility Administrators. The letter Identified the affected product, explained the recall situation, and asked firms to check their facility for the affected serial numbers. Consignees were asked to return the recalled products, and a replacement sling would be sent to them. Customers can contact Hill-Rom Technical Support at 800-445-3720, if they have any questions concerning this matter.
Quantity in commerce
10 units
Distribution
Worldwide Distribution -- US, Switzerland, Germany, Denmark, Finland, France, UK, Italy, Netherlands, Sweden, and Canada.
Product codes and lots
Serial Numbers: A032220, A032221, A032222, A032223, A032224, A032227, A032228 and A032229.