Date Initiated by Firm | July 01, 2008 |
Date Posted | September 20, 2008 |
Recall Status1 |
Terminated 3 on July 17, 2015 |
Recall Number | Z-2319-2008 |
Recall Event ID |
48747 |
Product Classification |
Lift, patient, non-ac-powered - Product Code FSA
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Product | Universal SlingBar 450 with Quick-release Hook
Product Number: 3156085
Used in combination with all lifts from Liko, i.e. mobile lifts and overhead lifts |
Code Information |
Affected serial numbers on sling bars: 1200101-1245680, 121204-121499, and 12222407-12225241 |
Recalling Firm/ Manufacturer |
Liko AB Alvik 7555 Lulea Sweden
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For Additional Information Contact | Ann Jordan 508-553-6642 |
Manufacturer Reason for Recall | A component securing the Universal SlingBar to the patient lift, may experience a nut unthreading resulting in the sling bar detaching from the lift causing the patient to fall. |
FDA Determined Cause 2 | Component design/selection |
Action | Liko North America ,the US Distributor, notified accounts by letter dated June 30, 2008 and provided a Field Safety Notice with Safety Inspection Procedures to performed on the lift prior to use. Replacement slingbars are being provided.
If you have questions, contact the Liko product distributor in your country. Contact information can be found at www.liko.com/int/distributors.asp. |
Distribution | Nationwide |
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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