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

FDA device recall Z-1396-2011 · posted 2011-02-23 · Terminated

Recall details

Recalling firm

Hill-Rom, Inc.

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.

Action taken

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.

Root cause

Pending

Status

Terminated

Product code

FSA

Quantity affected

10 units

Distribution

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

Date initiated

2011-02-09

Date posted

2011-02-23

Date terminated

2011-10-07

Location

Batesville, IN