Events

Recall of Device Recall Access Point Medical Heavy Duty Rollator

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Access Point Medical LLC.

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
    35919
  • Event Risk Class
    Class 2
  • Event Number
    Z-0154-2007
  • Event Initiated Date
    2006-06-20
  • Event Date Posted
    2006-11-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-06-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=47145
  • 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
    Rolling Walker - Product Code ITJ
  • Reason
    The fork component on the wheel of the rollator can break due to the use of incorrect manufacturing material and/or molding processes.
  • Action
    The recall was initiated by phone on or about 6/20/06, to determine how many Rollators the customer had in stock because they had received reports of Rollators coming out of the box with cracked forks. During the phone call, the customer was told that the recalling firm was bringing back their remaining inventory for inspection and that customer service would be calling them back to arrange for return. The recalling firm issued a '2nd Recall Notice' dated 10/10/06 via UPS between 10/11-13/06 explaining the reason for recall, requesting their customers to conduct a subrecall down to the consumer level and instructing that all of the Rollators be destroyed.

Device

Device Recall Access Point Medical Heavy Duty Rollator
  • Model / Serial
    All Rollators of this model number
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    Access Point Medical-Heavy Duty Rollator (rolling walker), Product Code RL12010HD, with seat, backrest, 8'' wheels with locks, maximum capacity 400 lbs.,and wire basket. Manufactured for Access Point Medical, St. Louis, MO. Made in China
  • Manufacturer
    Access Point Medical LLC

Manufacturer

Access Point Medical LLC
  • Manufacturer Address
    Access Point Medical LLC, Three City Place Drive, Suite 750, St. Louis MO 63141
  • Source
    USFDA