Recall Z-1536-2012 ยท LLI Bed, Therapeutic, Ac-Powered, Adjustable Home-Use
GF Health Products, Inc./d.b.a.Basic American Metal Products
LUMEX A Graham-Field Brand, Bed End Sert. Low/Full-electric, Plastic Panels, Item 690-7604-000 Manufactured for : GF Heath Products, Inc., Atlanta, Georgia 30360 Made in China. LUMEX A Graham-Field Brand, Bed End Sert. Low/Full-electric, Walnut Panels, Item 690-7004-000 Manufactured for : GF Heath Products, Inc., Atlanta, Georgia 30360 Made in China. Therapeutic bed intended for home use.
| Date | May 11, 2012 (initiated Apr 17, 2012) |
| Status | Terminated |
| Reason | 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 |
| Root cause | Component change control |
| Action | 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. |
| Quantity | 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, SC, TN, TX, UT, VA, WA, WV, and WI and the countries of EL SALVADOR, CHILE, GUATEMALA, TRINIDAD, TOB |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.