FDA Recall Terminated

Lumex Walkabout Lite Four-Wheel Rollator, Manufactured for: Graham-Field Health Products, Atlanta, Georgia 30360.

Recall: Z-0772-2007 · Initiated April 2, 2007

Recall

Recall Number
Z-0772-2007
Event Number
37747
FEI Number
2427360
Product Code
ITJ
Status
Terminated
Root Cause
Other
Initiated
April 2, 2007
Posted
May 5, 2007
Terminated
January 12, 2010
Address
2935 Northeast Pkwy, Graham Field Atlanta, Atlanta, GA, 30360-2808

Description

Lumex Walkabout Lite Four-Wheel Rollator, Manufactured for: Graham-Field Health Products, Atlanta, Georgia 30360.

Reason

The caster bolt stem/screw may loosen over time causing the wheel to come off.

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.

Distribution

U.S. Nationwide, Costa Rica, Ecuador, El Salvador, Guatemala, and Santo Domingo

Quantity

13,300 units