Events

Recall of Device Recall Mechanical Walker/Rollator

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Essential Medical Supply, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    52129
  • Event Risk Class
    Class 2
  • Event Number
    Z-1674-2009
  • Event Initiated Date
    2009-05-08
  • Event Date Posted
    2009-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-09-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82166
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Mechanical Walker - Product Code ITJ
  • Reason
    The caster may separate from the frame completely causing injury to the user.
  • 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.

Device

Device Recall Mechanical Walker/Rollator
  • Model / Serial
    W1700 (R and B); Lot / Serial Nos.: KLD-E07090001 through KLD-E08020570
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide distribution.
  • Product Description
    Essential Medical Supply brand Essential Rollator with Loop Hand Brakes, models W1700B (Blue) and W1700R (Red), Four Wheel Aluminum Walker/Rollator
  • Manufacturer
    Essential Medical Supply, Inc.

Manufacturer

Essential Medical Supply, Inc.
  • Manufacturer Address
    Essential Medical Supply, Inc., 6420 Hazeltine National Dr, Orlando FL 32822-5121
  • Manufacturer Parent Company (2017)
    Essential Medical Supply Inc
  • Source
    USFDA