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Class 2 Device Recall Comfort Sling Plus Model 300 |
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Date Initiated by Firm |
February 09, 2011 |
Date Posted |
February 23, 2011 |
Recall Status1 |
Terminated 3 on October 07, 2011 |
Recall Number |
Z-1396-2011 |
Recall Event ID |
57861 |
Product Classification |
Non-AC-Powered Patient Lift - Product Code FSA
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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 IN 47006
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For Additional Information Contact |
812-934-7777
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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.
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FDA Determined Cause 2 |
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. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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