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Terminated

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

FDA Recall Z-0772-2007 · Posted 2007-05-05

Recalling FirmGraham Field Atlanta
Recall StatusTerminated
Product CodeITJ
Date Initiated2007-04-02
Date Terminated2010-01-12
Product Quantity13,300 units

Reason for Recall

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

Firm 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.

Root Cause

Other

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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