Events

Recall of Transport Chair and Rollator in 1

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Silver Star Brands.

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
    69487
  • Event Risk Class
    Class 2
  • Event Number
    Z-0216-2015
  • Event Initiated Date
    2014-10-10
  • Event Date Posted
    2014-11-14
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130754
  • 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
    Wheelchair, mechanical - Product Code IOR
  • Reason
    Silver star brands is recalling the transport chair and rollator in one because they have received several reports of the wheel assembly failing resulting in damaged wheels.
  • Action
    Consignees were sent on 10/10/2014 an Easy Comforts "Urgent: Rollator Recall" letter dated October 10, 2014. The letter described the problem and the product involved in the recall. Advised consignees to stop using the product immediately. The consignees can contact the Product specialist at Easy Comforts at 1-888-327-2390 Monday though Friday from 7:30 am to 3:30 pm central time.

Device

Transport Chair and Rollator in 1
  • Model / Serial
    SKU 348709 404, SKU348709 605
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including the states of AL, AZ, AR, CA, CO, CT, FL, GA, HI, IL, IN, IA, KS, LA, MD, MI, MO, MT, NE, NV,NH, NM, NY, NC, OH,OK, and PA.
  • Product Description
    Transport Chair and Rollator in 1, Model HE21630011 Burgundy and HE21630011 Blue. || This is a walker/rolling chair. Used to assist injured and infirm people to walk or be ambulatory.
  • Manufacturer
    Silver Star Brands

Manufacturer

Silver Star Brands
  • Manufacturer Address
    Silver Star Brands, 2155 S Oakwood Rd, Oshkosh WI 54904-6359
  • Source
    USFDA