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U.S. Department of Health and Human Services

Class 2 Device Recall ENDURANCE HD

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  Class 2 Device Recall ENDURANCE HD see related information
Date Initiated by Firm December 21, 2009
Date Posted August 25, 2010
Recall Status1 Terminated 3 on February 21, 2012
Recall Number Z-2269-2010
Recall Event ID 54810
Product Classification Mechanical Walker - Product Code ITJ
Product ESSENTIAL MEDICAL SUPPLY, INC. ENDURANCE HD, BUILT TO LAST, HEAVY DUTY FOUR WHEEL WALKER for users up to 500 pounds.

Model W1801B- Blue, UPC 7 54756 91802 6 all serial numbers.
W1801R-Red, UPC 7 54756 91803 3 all serial numbers.

The Endurance HD is a four wheeled steel frame walker with loop locking wheel locks, a padded seat and an under seat tote for carrying personal articles.

Used to assist in ambulation and specifically for obese patients weighing up to 500 pounds.

Warranty Card: "...lifetime of the original purchaser...". Usable life of a walker is 5 years but firm will warranty for lifetime of the original purchaser.
Code Information All SS Numbers 05F0002740 to RPN090702497.
Recalling Firm/
Manufacturer		 Essential Medical Supply, Inc.
6420 Hazeltine National Dr
Orlando FL 32822
For Additional Information Contact
407-770-0710
Manufacturer Reason
for Recall		 Essential Medical Supply, Inc. is recalling W1801B and W1801R Endurance HD Walkers due to recent reports and tests that show the front caster may detach from the frame. The potential failures include a collapse of the plastic fork or shearing of the stud attaching the caster to the frame.
FDA Determined
Cause 2		 Other
Action All Consignees were mailed an Urgent: Product Recall W1801B and W1801R Endurance HD Walkers notification on December 30, 2009. All notifications were sent first class mail in a 9" X 6" envelope. Response cards were included. The letter identified the affected product and the reason for recall. Customers were asked to examine their inventory for affected product and to discontinue further use or distribution of the product. If the product was further distributed, customers should contact their customers, advise them of the recall and have them return the units to them. Customers should follow the instructions provided for return and replacement of units.
Quantity in Commerce 2,954 units
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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