Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1882-2017Class II

The Savaria Stairfriend is a Residential, commercial, indoor, stair lift for curved stairs

Savaria Concord Lifts, Inc. / initiated 2017-04-12 / Terminated / root cause: manufacturing process

Savaria Concord Lifts, Inc. began a recall of The Savaria Stairfriend is a Residential, commercial, indoor, stair lift for curved stairs on . FDA classified it as Class II and gives the reason as "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". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-1882-2017
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Savaria Concord Lifts, Inc.
Product
The Savaria Stairfriend is a Residential, commercial, indoor, stair lift for curved stairs.
Product code
ILK Transport, Patient, Powered
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 .
Root cause tag
manufacturing process
FDA root cause
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.
Product codes and lots
s/n or lot number - 690009 thru 690235

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1882-2017
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1882-2017Class IITerminatedVoluntary: Firm initiated