Recall Z-0142-2015
Briggs Medical Service Company d.b.a. Mabis · initiated June 5, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: 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
Reason for recall
There have been 5 customer reports of a 501-1018 series DMI Rollator Transport Chair collapsing during use.
FDA-determined cause: Device Design
Action taken
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.
Details
- Recall number
- Z-0142-2015
- Initiated
- June 5, 2014
- Posted by FDA
- October 28, 2014
- Terminated
- November 29, 2017
- Product code
- ITJ – Walker, Mechanical
- Quantity
- 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
- Recalling firm
- Briggs Medical Service Company d.b.a. Mabis, Waukegan, IL