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U.S. Department of Health and Human Services

Class 2 Device Recall Mechanical Walker/Rollator

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  Class 2 Device Recall Mechanical Walker/Rollator see related information
Date Initiated by Firm May 08, 2009
Date Posted July 20, 2009
Recall Status1 Terminated 3 on September 15, 2010
Recall Number Z-1674-2009
Recall Event ID 52129
Product Classification Mechanical Walker - Product Code ITJ
Product Essential Medical Supply brand Essential Rollator with Loop Hand Brakes, models W1700B (Blue) and W1700R (Red), Four Wheel Aluminum Walker/Rollator
Code Information W1700 (R and B); Lot / Serial Nos.: KLD-E07090001 through KLD-E08020570 
Recalling Firm/
Manufacturer		 Essential Medical Supply, Inc.
6420 Hazeltine National Dr
Orlando FL 32822-5121
For Additional Information Contact Sue Mays
407-770-0710
Manufacturer Reason
for Recall		 The caster may separate from the frame completely causing injury to the user.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
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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