Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Transport Chair and Rollator in 1

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Transport Chair and Rollator in 1 see related information
Date Initiated by Firm October 10, 2014
Date Posted November 14, 2014
Recall Status1 Terminated 3 on May 08, 2019
Recall Number Z-0216-2015
Recall Event ID 69487
Product Classification Wheelchair, mechanical - Product Code IOR
Product 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.
Code Information SKU 348709 404, SKU348709 605
Recalling Firm/
Manufacturer		 Silver Star Brands
2155 S Oakwood Rd
Oshkosh WI 54904-6359
For Additional Information Contact Cheri Kupczyk
920-231-3800
Manufacturer Reason
for Recall		 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..
FDA Determined
Cause 2		 Device Design
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.
Quantity in Commerce 129
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
-
-