Z-1674-2009
Essential Medical Supply brand Essential Rollator with Loop Hand Brakes, models W1700B (Blue) and W1700R...
Essential Medical Supply, Inc. / initiated 2009-05-08 / Terminated / root cause: design
Essential Medical Supply, Inc. began a recall of Essential Medical Supply brand Essential Rollator with Loop Hand Brakes, models W1700B (Blue) and W1700R (Red), Four Wheel Aluminum Walker/Rollator on . The reason FDA records is "The caster may separate from the frame completely causing injury to the user". As of , the recall status on record is Terminated, and MDM tags the root cause as design.
Recall record
- Recall number
- Z-1674-2009
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Essential Medical Supply, Inc.
- Product
- Essential Medical Supply brand Essential Rollator with Loop Hand Brakes, models W1700B (Blue) and W1700R (Red), Four Wheel Aluminum Walker/Rollator
- Product code
- ITJ Walker, Mechanical
- Reason for recall
- The caster may separate from the frame completely causing injury to the user.
- Root cause tag
- design
- FDA 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 Medical Supply or destroy the products and send proof of destruction.
- Quantity in commerce
- 2265
- Distribution
- Nationwide distribution.
- Product codes and lots
- W1700 (R and B); Lot / Serial Nos.: KLD-E07090001 through KLD-E08020570
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
