FDA Recall Terminated

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.

Recall: Z-1396-2011 · Initiated February 9, 2011

Recall

Recall Number
Z-1396-2011
Event Number
57861
Firm
Hill-Rom, Inc. 125 E Pearl St 1069 State Route 46 East Batesville IN 47006
FEI Number
1824206
Product Code
FSA
Status
Terminated
Root Cause
Pending
Initiated
February 9, 2011
Posted
February 23, 2011
Terminated
October 7, 2011

Description

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.

Reason

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.

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.

Distribution

Worldwide Distribution -- US, Switzerland, Germany, Denmark, Finland, France, UK, Italy, Netherlands, Sweden, and Canada.

Quantity

10 units