Recall Z-1396-2011
Hill-Rom, Inc. · initiated February 9, 2011
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.
Codes / lots: Serial Numbers: A032220, A032221, A032222, A032223, A032224, A032227, A032228 and A032229.
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-determined cause: Pending
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.
Details
- Recall number
- Z-1396-2011
- Initiated
- February 9, 2011
- Posted by FDA
- February 23, 2011
- Terminated
- October 7, 2011
- Product code
- FSA – Lift, Patient, Non-Ac-Powered
- Quantity
- 10 units
- Distribution
- Worldwide Distribution -- US, Switzerland, Germany, Denmark, Finland, France, UK, Italy, Netherlands, Sweden, and Canada.
- Recalling firm
- Hill-Rom, Inc., Batesville, IN