Recall Z-1674-2009 ยท ITJ Walker, Mechanical
Essential Medical Supply, Inc.
Essential Medical Supply brand Essential Rollator with Loop Hand Brakes, models W1700B (Blue) and W1700R (Red), Four Wheel Aluminum Walker/Rollator
| Date | Jul 20, 2009 (initiated May 8, 2009) |
| Status | Terminated |
| Reason | The caster may separate from the frame completely causing injury to the user. |
| 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 Medic |
| Quantity | 2265 |
| Distribution | Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.