Events

Recall of Device Recall DMI Rollator Transport Chair

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Briggs Medical Service Company d.b.a. Mabis.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    64774
  • Event Risk Class
    Class 2
  • Event Number
    Z-0142-2015
  • Event Initiated Date
    2014-06-05
  • Event Date Posted
    2014-10-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-11-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117032
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Walker, mechanical - Product Code ITJ
  • Reason
    There have been 5 customer reports of a 501-1018 series dmi rollator transport chair collapsing during use.
  • 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.

Device

Device Recall DMI Rollator Transport Chair
  • Model / Serial
    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
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • 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 Description
    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.
  • Manufacturer
    Briggs Medical Service Company d.b.a. Mabis

Manufacturer

Briggs Medical Service Company d.b.a. Mabis
  • Manufacturer Address
    Briggs Medical Service Company d.b.a. Mabis, 1931 Norman Dr N, Waukegan IL 60085-6715
  • Manufacturer Parent Company (2017)
    Briggs Medical Service Company
  • Source
    USFDA