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Class 2 Device Recall Liko |
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| Date Initiated by Firm |
January 09, 2006 |
| Date Posted |
April 26, 2006 |
| Recall Status1 |
Terminated 3 on October 25, 2006 |
| Recall Number |
Z-0791-06 |
| Recall Event ID |
34463 |
| Product Classification |
Lift, Patient, Non-Ac-Powered - Product Code FSA
|
| Product |
Liko Universal Slingbar 450 (aluminum) used with the Viking L Patient Lift |
| Code Information |
Serial Numbers: 7200202 - 7200216; 7200244 - 7200245; 7200250 - 7200257; 7200260 - 7200262 Expanded recall: Viking L: Serial Nimbers: 7200201 through 7200284 |
Recalling Firm/
Manufacturer |
Liko, Inc.
842 Upper Union Street, Suite 4
Franklin MA 02038
|
| For Additional Information Contact |
Ann Jordan
508-553-3993
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Manufacturer Reason
for Recall |
The swivel adapter which is mounted directly above the slingbar's split center bolt could be removed and allow the slingbar to be improperly mounted directly into the aluminum link arm. This could cause an unsafe transfer. Patient may fall.
|
FDA Determined
Cause 2 |
Other |
| Action |
Liko notified Distributors of the recall by letter on 1/9/06 via UPS and provided replacement Slingbars Version 2.
Expanded Recall:
On 6/20/06, Liko sent a 2nd recall letter expanding the recall to additonal serial numbers via Certified Mail. |
| Quantity in Commerce |
38 units |
| Distribution |
IL, MA, MO, PA, TN, |
| 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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