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Class 2 Device Recall Transport Chair and Rollator in 1 |
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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
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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
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For Additional Information Contact |
Cheri Kupczyk 920-231-3800
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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..
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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
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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.
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