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U.S. Department of Health and Human Services

Class 2 Device Recall LUMEX A GrahamField Brand, Bed End Sert

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 Class 2 Recall
LUMEX A GrahamField Brand, Bed End Sert
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Date Posted May 11, 2012
Recall Status1 Terminated on July 15, 2013
Recall Number Z-1536-2012
Recall Event ID 61527
Product Classification Bed, Therapeutic, Ac-Powered, Adjustable Home-Use - Product Code LLI
Product 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.
Code Information Lot #'s: A0309, A0501, A0609, B0309, B0501, B0609, C0309,C0501 , D0309,E0309, F0309 Lot/serial number: A0309: 6970400900001 6970400900002 6970400900003 6970400900004 6970400900005 6970400900006 6970400900007 6970400900008 6970400900009 6970400900010 6970400900011 6970400900012 6970400900013 6970400900014 6970400900015 6970400900016 6970400900017 6970400900018 6970400900019 6970400900020 6970400900021 6970400900022 6970400900023 6970400900024 6970400900025 6970400900026 6970400900027 6970400900028 6970400900029 6970400900030 6970400900031 6970400900032 6970400900033 6970400900034 6970400900035 6970400900036 6970400900037 6970400900038 6970400900039 6970400900040 6970400900041 6970400900042 6970400900043 6970400900044 6970400900045 6970400900046 6970400900047 6970400900048 6970400900049 6970400900050 6970400900051 6970400900052 6970400900053 6970400900054 6970400900055 6970400900056 6970400900057 6970400900058 6970400900059 6970400900060 6970400900061 6970400900062 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6976040901448 6976040901449 B0309: 6970400900151 6970400900152 6970400900153 6970400900154 6970400900155 6970400900156 6970400900157 6970400900158 6970400900159 6970400900160 6970400900161 6970400900162 6970400900163 6970400900164 6970400900165 6970400900168 6970400900169 6970400900170 6970400900171 6970400900172 6970400900173 6970400900174 6970400900175 6970400900176 6970400900177 6970400900178 6970400900179 6970400900180 6970400900182 6970400900183 6970400900184 6970400900185 6970400900186 6970400900187 6970400900188 6970400900189 6970400900190 6970400900192 6970400900193 6970400900194 6970400900195 6970400900196 6970400900197 6970400900198 6970400900199 6970400900200 6970400900201 6970400900202 6970400900205 6970400900206 6970400900208 6970400900210 6970400900211 6970400900212 6970400900213 6970400900214 6970400900215 6970400900216 6970400900217 6970400900218 6970400900219 6970400900220 6970400900221 6970400900222 6970400900225 6970400900226 6970400900228 6970400900229 6970400900230 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6976040901412 6976040901413 6976040901414 6976040901415 6976040901416 D0309: 6970400900551 6970400900552 6970400900553 6970400900554 6970400900555 6970400900556 6970400900557 6970400900558 6970400900559 6970400900560 6970400900561 6970400900562 6970400900563 6970400900564 6970400900565 6970400900567 6970400900568 6970400900570 6970400900571 6970400900572 6970400900573 6970400900574 6970400900576 6970400900577 6970400900578 6970400900579 6970400900580 6970400900582 6970400900583 6970400900585 6970400900586 6970400900587 6970400900588 6970400900589 6970400900590 6970400900591 6970400900592 6970400900593 6970400900594 6970400900595 6970400900596 6970400900597 6970400900598 6970400900599 6970400900600 6970400900601 6970400900602 6970400900604 6970400900606 6970400900607 6970400900608 6970400900609 6970400900610 6970400900611 6970400900612 6970400900613 6970400900614 6970400900615 6970400900616 6970400900617 6970400900618 6970400900620 6970400900621 6970400900622 6970400900623 6970400900624 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Recalling Firm/
Manufacturer
GF Health Products, Inc./d.b.a.Basic American Metal Products
336 Trowbridge Dr
Fond Du Lac, Wisconsin 54937-9103
Consumer Instructions Contact the recalling firm for information
Manufacturer 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
FDA Determined
Cause 2
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): 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 in Commerce 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, TOBAGO, and BAHAMAS.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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