Recall Z-1674-2009
Essential Medical Supply, Inc. · initiated May 8, 2009
Product
Essential Medical Supply brand Essential Rollator with Loop Hand Brakes, models W1700B (Blue) and W1700R (Red), Four Wheel Aluminum Walker/Rollator
Codes / lots: W1700 (R and B); Lot / Serial Nos.: KLD-E07090001 through KLD-E08020570
Reason for recall
The caster may separate from the frame completely causing injury to the user.
FDA-determined cause: Device Design
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.
Details
- Recall number
- Z-1674-2009
- Initiated
- May 8, 2009
- Posted by FDA
- July 20, 2009
- Terminated
- September 15, 2010
- Product code
- ITJ – Walker, Mechanical
- Quantity
- 2265
- Distribution
- Nationwide distribution.
- Recalling firm
- Essential Medical Supply, Inc., Orlando, FL