Events

Recall of Device Recall ENDURANCE HD

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
    54810
  • Event Risk Class
    Class 2
  • Event Number
    Z-2269-2010
  • Event Initiated Date
    2009-12-21
  • Event Date Posted
    2010-08-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-02-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89229
  • 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
    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.
  • 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.

Device

Device Recall ENDURANCE HD
  • Model / Serial
    All SS Numbers 05F0002740 to RPN090702497.
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    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.
  • Manufacturer
    Essential Medical Supply, Inc.

Manufacturer

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