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U.S. Department of Health and Human Services

Class 2 Device Recall DMI Rollator Transport Chair

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  Class 2 Device Recall DMI Rollator Transport Chair see related information
Date Initiated by Firm June 05, 2014
Date Posted October 28, 2014
Recall Status1 Terminated 3 on November 29, 2017
Recall Number Z-0142-2015
Recall Event ID 64774
Product Classification Walker, mechanical - Product Code ITJ
Product DMI Duro-Med Industries Rollator Transport Chair; Wheel Size: 7 1/4"; Overall Width: 23 1/2"; Seat Height: 21 1/4"; Seat Size: 14" x 12 3/4"; Handle Height: 31" - 36"; Width Between Handles: 18"; Weight: 19 Lbs;

Walking assistance device.
Code Information A) Model Number: 501-1018-0700; UPC Code: 0-41298-10187-1; Lot Numbers: 5628671109, 5628670111, 5628670211, 5628670711, 5628671211;    B) Model Number: 501-1018-2100; UPC Code: 0-41298-10182-6; Lots: 5628671109, 5628670111, 5628670211, 5628670711, 5628671211 
Recalling Firm/
Manufacturer		 Briggs Medical Service Company d.b.a. Mabis
1931 Norman Dr N
Waukegan IL 60085-6715
For Additional Information Contact Ms. Jeri Hill
847-680-6811
Manufacturer Reason
for Recall		 There have been 5 customer reports of a 501-1018 series DMI Rollator Transport Chair collapsing during use.
FDA Determined
Cause 2		 Device Design
Action The firm, Briggs Healthcare, sent "URGENT PRODUCT RECALL" letters dated July 28, 2014 to all distributors, retailers and consumers. The letters included instructions for distributors and dealers to: 1) examine their inventory; 2) quarantine any affected products; 3) cease distribution of the affected products; and, 4) complete and return the attached Customer Recall Acknowledgement Form. Distributors and dealers who further distributed the products were also instructed to notify their customers of this recall by forwarding a copy of the enclosed consumer notification letter and its associated documents. Distributors and dealers with questions about this recall can contact Briggs at 800-342-4426 (Monday - Friday, 8:00 AM - 6:00 PM EDT) or by e-mail at RecallCoord@briggscorp.com. The consumer-directed letter dated July 28, 2014 included instructions for consumers to examine their rollator transport chair to determine whether or not it is subject to the recall. If the consumer has the affected product, they should discontinue using it immediately and contact Briggs at 800--342-4426 (Monday - Friday, 8:00 AM - 6:00 PM EDT) or by e-mail at RecallCoord@briggscorp.com to arrange for the return of the product. Consumers will be given the option of receiving a cash voucher or a replacement product in exchange for the recalled product.
Quantity in Commerce 1,869 units
Distribution Worldwide Distribution: US (nationwide) including states of:US: Nationwide (AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY) + District of Columbia + Puerto Rico; and country of : Canada. ); FOREIGN: Canada
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.
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