Z-0772-2007

Lumex Walkabout Lite Four-Wheel Rollator, Manufactured for: Graham-Field Health Products, Atlanta, Georgia...

Name: Z-0772-2007 Lumex Walkabout Lite Four-Wheel Rollator, Manufactured for: Graham-Field Health Products, Atlanta, Georgia...
Creator: Graham Field Atlanta
Published: 2007-04-02
License: https://open.fda.gov/license/

GF Health Products, Inc. / initiated 2007-04-02 / Terminated

FDA source

Graham Field Atlanta began a recall of Lumex Walkabout Lite Four-Wheel Rollator, Manufactured for: Graham-Field Health Products, Atlanta, Georgia 30360 on 2007-04-02. The reason FDA records is "The caster bolt stem/screw may loosen over time causing the wheel to come off". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0772-2007
Status: Terminated
Initiated: 2007-04-02
Posted: 2007-05-05
Terminated: 2010-01-12
Recalling firm: GF Health Products, Inc.
Product: Lumex Walkabout Lite Four-Wheel Rollator, Manufactured for: Graham-Field Health Products, Atlanta, Georgia 30360.
Product code: ITJ Walker, Mechanical
Reason for recall: The caster bolt stem/screw may loosen over time causing the wheel to come off.
FDA root cause: Other
Action: Graham-Field notified all of its Durable Medical Equipment (DME) dealers involved in the distribution of these products by certified US Mail on April 3, 2007. They were made aware of the need to adjust the product to lessen the risk of injury and were provided a re-work kit. The distribution of DME dealers includes the announcement of the field correction to the DME dealer, the letter to send to the end-users, rework supplies, rework instructions and proof of compliance cards. Graham-Field instructed the DME dealers to adjust any impacted products on site, as well as, any delivered by end-users, customers or other impacted third parties to the DME dealer for correction. DME dealers will be compensated for performing the corrective action. The installation of the rework kit involves the installation of lock washers and Locitite and is described in more detail in the attached rework instructions. Graham-Field does not have direct access to end user names, however it plans to reach end-users by financially supporting a certified mailing from DME dealers to their individual customers notifying them of this field correction. A follow-up 60 day certified mailing will be performed for non-responders.
Quantity in commerce: 13,300 units
Distribution: U.S. Nationwide, Costa Rica, Ecuador, El Salvador, Guatemala, and Santo Domingo
Product codes and lots: Model numbers: RJ4300B, RJ4300D, RF4300G, RJ4300K, RJ4300R, and Imperial Model RF4400K. (Note: Models distributed after January 2007, serial numbers 120791 through 145254, are not subject to this correction)

Product code ITJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)