Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1674-2009

Essential Medical Supply brand Essential Rollator with Loop Hand Brakes, models W1700B (Blue) and W1700R...

Essential Medical Supply, Inc. / initiated 2009-05-08 / Terminated / root cause: design

Essential Medical Supply, Inc. began a recall of Essential Medical Supply brand Essential Rollator with Loop Hand Brakes, models W1700B (Blue) and W1700R (Red), Four Wheel Aluminum Walker/Rollator on . The reason FDA records is "The caster may separate from the frame completely causing injury to the user". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-1674-2009
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Essential Medical Supply, Inc.
Product
Essential Medical Supply brand Essential Rollator with Loop Hand Brakes, models W1700B (Blue) and W1700R (Red), Four Wheel Aluminum Walker/Rollator
Product code
ITJ Walker, Mechanical
Reason for recall
The caster may separate from the frame completely causing injury to the user.
Root cause tag
design
FDA root cause
Device Design
Action
Essential Medical Supply Inc issued a Notice of Quarantine Letter to all customers on 04/30/09, identifying affected products as W1700B & W1700R Essential Rollators, Serial #'s KLD-E07090001 through KLD-E08020570, received after 11/05/2007. Firm issued a Device Recall Letter to all direct customers on 05/08/09 instructing them to do the following: (1) segregate and quarantine any affected product; (2) identify and notify any customers that may received the affected products, instructing them to return the product to their dealer; and (3) either return the affected products to Essential Medical Supply or destroy the products and send proof of destruction.
Quantity in commerce
2265
Distribution
Nationwide distribution.
Product codes and lots
W1700 (R and B); Lot / Serial Nos.: KLD-E07090001 through KLD-E08020570