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U.S. Department of Health and Human Services

Class 2 Device Recall Hydration Station with Pedestal

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  Class 2 Device Recall Hydration Station with Pedestal see related information
Date Initiated by Firm May 15, 2007
Date Posted July 15, 2009
Recall Status1 Terminated 3 on July 05, 2012
Recall Number Z-1245-2009
Recall Event ID 51934
510(K)Number K003916  
Product Classification Cabinet, moist steam - Product Code IMB
Product Hydration Station with Pedestal (Part # E30003-01), Hydration Station with Pedestal & DVD (Part # E30003-01D), Sybaritic, Inc., 9229 James Avenue South, Minneapolis, MN 55431.
Code Information Serial Numbers: 206045779, SG2061042159, 206054856, 206054874, 205024943, 206055838, 206065900, 205086311, 205104399, 205044085, 205104389, SG2061052196, SG2061242331, 205026973, 205105418, 205124542, 205085303, 206045774, SG2061042139, 206025737, SG2061252335, SG2061042144, 205036004, 206054864, 206074978, SG2070142422, 206044815, 205114444, 206045777, 205106415, 205116435, 206064932, SG2070452617, 205026946, 205105397, 205044117, SG2070352558, 206055846, 205104413, 205114480, 205104402, 206034734, 206064954, 206045775, 206055872, 206065917, 2060742003, 205024996, 206024711, 206055879, 206064931, SG2070442571, SG2061242336, SG2061052167, SG2061252330, SG2061042152, 205016864, SG2070142362, 205114443, 205105419, 206044772, 206054883, SG2061252351, 205125523, 2060942089, SG2061142232, 206064949, 206065910, 205124550, 205115440, 206045781, 205085300, SG2061152280, 2060952083, 206075982, 206045773, 206064902, SG2070152435, 205016909, 206044770, 205114464, 206044801, 206075002, SG2061252339, 206035735, 205114456, 206045778, 206055860, 2060942063, 206054889, 206044814, SG2061152278, 205126569, 206075986, SG2070142383, SG2061052140 206054842, 206034728, SG2061042175, 206054854, SG2061152250, SG2061152223, 205024974, 205014893, 206045771, 205096337, 205105400, 205025988, SG2061042164, 205026938, 205046086, 205025939, 206065964, 205025978, SG2061252345, 205104390, 206044799, SG2061252338, SG2070152353, 206055855, SG2070442574, SG2070352513, SG2070452616, SG2070452610, 206045807, 206064965, 205114494, 205105408, 205015910, 206044802, SG2061242332, SG2070342501, 206044782, SG2070452608, SG2070152378, 205116476, 205104405, 205116431, 206074983, 206064938, 205116503, 206034730, SG2061242346, 206045767, 206035723, SG2061252341, 206045776, 206065945, SG2061252329, 204115767, 206064903, 205106395, 205106398, SG2060952114, 205116506, SG2070352490, SG2061142235, 206035729, 205016896, 204126827, 206044786, 206044783, 206064913, 206044812, 205105407, SG2060952109, SG2070242441, SG2070242446, 206065953, SG2070152389, 206054888, 205014920, SG2070442573, 206044818, 206045800, SG2061252347, 206064962, 206054880, 206045822, 206064946, 205034036, 205115495, 205115495, 206055885, 206065950, SG2070152391, 206055890, 2060952076, 206045787, SG2061052213, 206044823, SG2061242327, 206065942, SG2061052160, SG2060942123, 205094380, 205114468, 206035733, 205025976, SG2070152386, 206065936, SG2070142392, SG2061242344, 20634755, SG2061042204, 206054861, 206065901, SG2070452576, SG2070152382, SG2070452572, 205126515, 205125558, SG2061042205, SG2070142356, 206074994, 206034742, 205124565, 206045813, 205104428, 206044809, 206045808, SG2070252447, 205126527, 205024977, SG2060952113, 205105422, 206055868, SG2070242472, 205115460, SG2070142385, SG2070142385, SG2060942125, 206054891, SG2061052202, 206045824, 205105392, 205024984, 206075995, 206034732, 205026981, SG2061042199, SG2060952118, 205044116, 205016898, 205106393, 206045798, 205044087, 205096350, SG2061052177, SG2060952124, SG2070152417, SG2070342556, SG2070452622, SG2061252343, 204095524, SG2070142373, SG2070152407, SG2070142354, 206045817, 206065951, 206065963, SG2061242334, 205024937, 206045819, 2060655873, SG2070152364, SG2061042169, SG2060942119, SG2060952120, SG2061142269, SG2060942108, SG2060942105, 206054865, SG2070242440, 205114484, 205016923, SG2070142396, SG2070152399, 205084307, 206034721, SG2061042151, SG2061042171, SG2061152283, SG2061052168, 204095422, 206054850, 206065909, 206035724, 206045810, 205035068, SG2070142433, 206045784, 204125834, SG2070542669, 206055884, 206044820, SG2070152393, SG2061052161, 206055886, SG2061052172, SG2070152432, 206065944, 206034750, 206055859, SG2070142371, 205015895, 205024972, SG2070252454, SG2070252469, SG2070342551, SG2070352492, SG2070352552, 204096525, 204116734, SG2061252349, SG2070142355, 205106862, SG2060952115, 206074979, 206035727, 205114436, SG2061052141, 206064943, SG2070142411, SG2061252340, SG2070142434, SG2070352553, 206055858, SG2061042197, SG2061242350, 205046089, 205115493, 205014863, 206044785, SG2070152399, SG2070142394, SG2070252467, SG2070242481, SG2070342557, 205036066, SG2070152366, 205014894, SG2061052166, 2060942082, SG2070152395, SG2070152358, 206045805, SG2070442634, SG2070252444, SG2061042155, SG2061052176, 205116432, 205116511, 206026670, 206054887, 206075998, SG2060942104, SG2070252471, 206036720, SG2060942084, 205045088, 205124576, SG2061242333, 204116738, SG2061052150, SG2061052203, 205036042, SG2070152378, SG2070242482 and SG2070242488. 
Recalling Firm/
Manufacturer		 Sybaritic, Inc
9220 James Ave S
Bloomington MN 55431-2302
For Additional Information Contact Matt Makousky
952-703-5396
Manufacturer Reason
for Recall		 Sybaritic conducted a recall on the Hydration Station 806 because of the potential for hot water to spurt through steam ports into unit and cause burns. Also, potential for customers to inadvertently place their legs over the side wall of the unit directly onto the steam ports and cause burns. There were 18 injuries and 8 malfunctions reported.
FDA Determined
Cause 2		 Device Design
Action Sybaritic, Inc. issued a letter dated May 15, 2007 addressed to "Hydration Station Customer". The letter informed the customer of the new 2007 Hydration Station Upgrade Improvement Kits including instructions and advised the customer to coordinate the installation of the components with their Technical Service Department. Further questions can be addressed to Sybaritic, Inc. Technical Administration at 1-800-445-8418 extension 373.
Quantity in Commerce 370
Distribution Worldwide Distribution - US including states of AL, AZ, CA, CO, CT, FL, GA, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, MI, NE, NV, NH, NJ, NM, NY, NC, OH, OR, PA, SC, TN, TX, UT, VA, WA, WV and WI and CANADA.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = IMB and Original Applicant = SCANDIA MANUFACTURING LTD.
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