LUMEX A Graham-Field Brand, Bed End Sert. Low/Full-electric, Plastic Panels, Item 690-7604-000 Manufactured for : GF Hea

FDA device recall Z-1536-2012 · posted 2012-05-11 · Terminated

Recall details

Recalling firm

GF Health Products, Inc./d.b.a.Basic American Metal Products

Reason for recall

GF Health Products, Inc., is conducting a recall on the Lumex Patriot Full Electric Homecare "Bed Ends" manufactured 3/27/09, 5/9/09, 5/30/09 and 6/20/09. The supplier deviated from the print specifications of a machined pin to a sheared pin. This deviation has the potential to provide room for the pin to move during use. If failure were to occur, the bed could descend rapidly causing non-typic

Action taken

GF Health Products, Inc. sent an "URGENT CORRECTION AND REMOVAL" letter dated April 17, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to immediately cease use of the affected product, secure the product, and to prevent the product from further distribution to customers and end users. Contact the firm at 1-800-556-6508 for questions regarding this notice.

Root cause

Component change control

Status

Terminated

Product code

LLI

Quantity affected

3095 pairs of bed ends

Distribution

Worldwide Distribution-USA (nationwide) including the states of AL, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, S

Date initiated

2012-04-17

Date posted

2012-05-11

Date terminated

2013-07-15

Location

Fond Du Lac, WI