Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0142-2015Class II

DMI Duro-Med Industries Rollator Transport Chair; Wheel Size: 7 1/4"; Overall Width: 23 1/2"; Seat Height: 21...

DMS Holdings, Inc. / initiated 2014-06-05 / Terminated / root cause: design

Briggs Medical Service Company d.b.a. Mabis began a recall of 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... on . FDA classified it as Class II and gives the reason as "There have been 5 customer reports of a 501-1018 series DMI Rollator Transport Chair collapsing during use". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-0142-2015
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
DMS Holdings, Inc.
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.
Product code
ITJ Walker, Mechanical
Reason for recall
There have been 5 customer reports of a 501-1018 series DMI Rollator Transport Chair collapsing during use.
Root cause tag
design
FDA root cause
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 [email protected]. 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 [email protected] 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
Product codes and 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

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-0142-2015
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-0142-2015Class IITerminatedVoluntary: Firm initiated