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

FDA device recall Z-1674-2009 · posted 2009-07-20 · Terminated

Recall details

Recalling firm

Essential Medical Supply, Inc.

Reason for recall

The caster may separate from the frame completely causing injury to the user.

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

ITJ

Quantity affected

2265

Distribution

Nationwide distribution.

Date initiated

2009-05-08

Date posted

2009-07-20

Date terminated

2010-09-15

Location

Orlando, FL