Date Initiated by Firm |
April 12, 2017 |
Create Date |
April 27, 2017 |
Recall Status1 |
Terminated 3 on October 16, 2017 |
Recall Number |
Z-1882-2017 |
Recall Event ID |
77042 |
Product Classification |
Transport, patient, powered - Product Code ILK
|
Product |
The Savaria Stairfriend is a Residential, commercial, indoor, stair lift for curved stairs. |
Code Information |
s/n or lot number - 690009 thru 690235 |
Recalling Firm/ Manufacturer |
Savaria Concord Lifts, Inc. 2 Walker Dr Brampton Canada
|
Manufacturer Reason for Recall |
Savaria Concord Lifts has decided to initiate a recall of the Stairfriend, because of product defect. The product defect relates to poor quality of welding holding the seat post .
|
FDA Determined Cause 2 |
Nonconforming Material/Component |
Action |
The firm plans to notify its customers thru the phone and also via the dealers it sells it product too. |
Quantity in Commerce |
226 |
Distribution |
North America / South America, please see attached list. |
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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