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U.S. Department of Health and Human Services

Class 2 Device Recall Comfort Sling Plus Model 300

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 Class 2 Recall
Comfort Sling Plus Model 300
see related information
Date Posted February 23, 2011
Recall Status1 Terminated on October 07, 2011
Recall Number Z-1396-2011
Recall Event ID 57861
Product Classification Lift, Patient, Non-Ac-Powered - Product Code FSA
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.
Code Information Serial Numbers: A032220, A032221, A032222, A032223, A032224, A032227, A032228 and A032229.
Recalling Firm/
Manufacturer
Hill-Rom, Inc.
125 E Pearl St
1069 State Route 46 East
Batesville, Indiana 47006
Manufacturer 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 2
OTHER/UNDETERMINED: Under Investigation by the firm
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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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