Recall Z-0772-2007 ยท ITJ Walker, Mechanical
Graham Field Atlanta
Lumex Walkabout Lite Four-Wheel Rollator, Manufactured for: Graham-Field Health Products, Atlanta, Georgia 30360.
| Date | May 5, 2007 (initiated Apr 2, 2007) |
| Status | Terminated |
| Reason | The caster bolt stem/screw may loosen over time causing the wheel to come off. |
| 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-user |
| Quantity | 13,300 units |
| Distribution | U.S. Nationwide, Costa Rica, Ecuador, El Salvador, Guatemala, and Santo Domingo |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.