NRAC Issue #1638 ADDENDUM July 10, 2007 --------------------------------------------------------------------------- Route To ____________________________________ Status ______________________ PRODUCT a) Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required) base; Model 801763 RECALL NUMBER # Z-0929-2007 PRODUCT b) Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required) base; Model 801764. (Not distributed within the United States) RECALL NUMBER # Z-0930-2007 CODE a) Serial numbers 0011 through 0039, 0041 through 0308, 0310 through 0313, 0315, 0316, 0319 through 0321 and 0324 may be affected by this issue. Serial numbers 0238 and 0282 have been corrected to date b) Serial numbers 0006 through 0066, 0100 through 0144, 0146, 0147 and 0149 may be affected by this issue. Serial number 0046 have been corrected to date MANUFACTURED & RECALLED BY Terumo Cardiovascular Systems Corp., Ann Arbor, MI QUANTITY 416 units DISTRIBUTION Nationwide and Internationally REASON System 1 power supply may electrically short to the main console, disrupting normal system operation by causing unexpected re-setting or shutdown of pumps and modules, false alarms and/or overheating and failure of the central control monitor. --------------------------------------------------------------------------- Route To ____________________________________ Status ______________________ PRODUCT EDTA, Disodium Salt Dihydrate, USP (Ethylenediamine Tetraacetic Acid, Disodium Salt Dihydrate), bulk drug for laboratory and commercial manufacturing use packaged in 500 g plastic bottles and 12 Kg plastic pails, catalogue numbers S312 and S316, CAS 6381-92-6 RECALL NUMBER # D-831-2007 CODE Lots: 066078 and 065543 MANUFACTURER Indian Chem-Port, Makarpura Baroda, India RECALLED BY Thermo Fisher Scientific Co., LLC, Fair Lawn, NJ QUANTITY 72.5 Kg DISTRIBUTION Nationwide and Canada REASON Product exceeds USP specification for nitrilotriacetic acid impurity. --------------------------------------------------------------------------- Route To ____________________________________ Status ______________________ PRODUCT a) Dr.cool Toothpaste Coolmint, Net Wt 120g, labeled ingredients include Sodium Monoflurophosphate 0.5% and Diglycol RECALL NUMBER # D-832-2007 PRODUCT b) Coolmint Toothpaste and Superdent Coolmint Toothpaste with toothbrush, Net Wt 120g, labeled ingredients include Sodium Monoflurophosphate 0.5% and Diglycol RECALL NUMBER # D-833-2007 PRODUCT c) Everfresh Assortment Toothpaste and Everfresh 1 + 1 Assortment Toothpaste with toothbrush, 25ml, labeled as "Cavity Fighter" RECALL NUMBER # D-834-2007 CODE a) Bar Code: 6926597170008 b) Bar Code: 6926597170015 c) Bar Code: 6926597089539 MANUFACTURER Goldcredit International Enterprises, Wuxi, Jiangsu, China RECALLED BY MainStar America, LLC, Miami, FL QUANTITY 4,966 units DISTRIBUTION FL, PR, and Guatemala REASON Toothpaste from China that contains the poisonous chemical diethylene glycol (DEG). --------------------------------------------------------------------------- Route To ____________________________________ Status ______________________ PRODUCT Crescent brand toothpaste & Crescent toothpaste with toothbrush, Net Wt 181g, labeled ingredients include Sodium Monofluorophosphate O.7% and Sorbitol RECALL NUMBER # D-829-2007 CODE All lots MANUFACTURER Shandong Chiping Foreign Trade Prod, Taiyun, China RECALLED BY H & Y Trading Co., Capitol Heights, MD QUANTITY 300 tubes DISTRIBUTION MD and D.C. REASON Toothpaste from China may contain the poisonous chemical diethylene glycol (DEG). --------------------------------------------------------------------------- Route To ____________________________________ Status ______________________ PRODUCT HDllXE Diagnostic Ultrasound System RECALL NUMBER # Z-0987-2007 CODE DOMESTIC SERIAL NUMBERS: US20771685, US30771865, US20670392, US20670393, US10771621, US10771622, USD0671510, US40670541, US10771620, USD0671532, USD0570096, US30771809, US50670631, USN0671407, USO0671271, US10670319, US40670573, US10670272, US30670502, US80671079, USN0671418, USD0570114, US60670879, US70670912, US60670757, US60670840, US40670600, US90671178, US20530061, USO0531087, US30771858, US10670304, US30771847, US30771848, US20771674, US90671170, USN0531256, USN0570005, US10771640, US30670501, USD0671542, US20771675, USN0671406, USD0671505, USD0671553, USN0671320, US60670861, US60670862, USO0671263, USN0671423, USD0671548, USO0671289, USO0671290, US50670707, USN0671319, US70670975, US80671083, US10670314, US10670315, US10670316, US10670317, US90531014, US70670906, USN0671323, US80670990, US50670673, US70670947, US80670987, US80670997, US90671154, US70670913, US60670880, USD0671475, US30771766, US20771672, USD0671554, USD0671497, USN0671367, USN0671410, USD0671572, US20771738, US30670521, USN0671326, USO0671285, USO0671286, US70670915, US20771726, USD0671533, USN0671413, USN0671414, US20771689, USD0671556, US70670914, US80671040, US60670777, US80670991, US10771596, US90404706, USO0671311, US60670872, US10771610, US20771683, USN0671360, USO0671288, USN0570031, USO0671260, US30771793, US20771696, US20771697, US20771739, US10771658, USD0671504, USD0531367, US10771647, US80671008, USO0671291, US30670509, USO0671294, US30771790, US10670288, US10670282, USD0671498, USN0671322, USO0671287, US50670737, US90671165, US90671117, USN0671408, USD0671527, US80670992, US30771835, US10670296, USO0671316, USO0671317, USN0531237, US30771831, US30771830, USN0570036, USN0570044, US10771651, US60670841, USN0531226, US10771641, US10771638, USO0671293, US30771782, USO0671304, US10771623, US10771660, US10771661, US30670410, US60670873, US90671161, USD0671567, USN0671370, USD0570200, US30670411, USD0570207, US40670540, US80671084, US70670953, US10771630, US10771631, USO0671254, USD0671550, US50670657, US10771580, US30771827, USD0570161, USD0671490, US30771771, USO0671315, USN0671341, US30771772, US20670366, USO0671214, USD0671531, USN0671362, USN0671321, USN0671422, US30771774, US30771775, USD0671493, USN0671325, USN0671353, US20771729, USN0671378, USO0671212, US20530091, USD0671511, USD0671555, US20771686, USD0570195, US60530418, USN0531243, USD0671546, USD0671547, US70670955, US10771576 MANUFACTURED & RECALLED BY Philips Medical Systems, Bothell, WA QUANTITY 562 units DISTRIBUTION Nationwide and Internationally REASON Potential for erroneous measurements which may lead to incorrect diagnosis based upon the presence of an inaccurate, undetectable error in clinical measurement or calculation. If the user exits an imaging mode while Active Annotation is in use, the system can enter an undefined state where the image scale calibration may not match the scale of the on-screen measurements and graphics and possibly leading to erroneous measurements that may be off by plus or minus 10-50 percent. --------------------------------------------------------------------------- Route To ____________________________________ Status ______________________ PRODUCT a) GE OEC 9900 Elite Fluoroscopic X-ray System RECALL NUMBER # Z-0848-2007 PRODUCT b) GE OEC 9800 Fluoroscopic X-ray System RECALL NUMBER # Z-0849-2007 PRODUCT c) GE OEC 8800 Fluoroscopic X-ray System RECALL NUMBER # Z-0850-2007 PRODUCT d) GE OEC 6800 Fluoroscopic X-ray System RECALL NUMBER # Z-0851-2007 PRODUCT e) GE OEC 2800 mobile Fluoroscopic X-ray System RECALL NUMBER # Z-0852-2007 CODE a) Serial numbers: E2-0155, E2-0156, E2-0157, E2-0164, E2-0167, E2-0168, E2-0170 thru E2-0234, E2-0235-C, E2-0236 thru E2-0257, E2-0259, E2-7048-MH, E2-7050-MH, E2-7051-MH, E2-7058-MH, E2-7059-MH, E2-7060-MH, E2-7061-MH, E2-7062-MH, E2-7064-MH, E2-7065-MH, E2-7066-MH, E2-7067-MH, E2-7068-MH, E2-7069-CMH, E2-7070-MH, E2-7071-MH, E2-7072-MH, E2-7073-MH, E2-7074-MH, E2-7076-MH, E2-7077-CMH, E9-0037, E9-0085, E9-0088, E9-0089-G, E9-0090, E9-0093, E9-0094, E9-0095, E9-0098 thru E9-0103, E9-0108 thru E9-0153, E9-0155, E9-0156, E9-0157, E9-0158, E9-0159, E9-0162, E9-0163, E9-0164, E9-0165, E9-0170, E9-0171, E9-0172, E9-0173, E9-0178, E9-0183, ES-0041-G, ES-0069, ES-0071, ES-0072, ES-0078, ES-0084-G, ES-0086-G, ES-0087, ES-0088, ES-0089, ES-0090, ES-0092-CH, ES-0096, ES-0097, ES-0098, ES-0099-CH, ES-0101-CH, ES-0103, ES-0104, ES-0106 thru ES-0130, ES-0131-H, ES-0132 thru ES-0154, ES-0155-H, ES-0156, ES-0157, ES-0158, ES-0159, ES-0160, ES-0162-G thru ES-0167-G, ES-0169-CH, ES-0170, ES-0171, ES-0172, ES-0173, ES-0175, ES-0176, ES-0177, ES-0178, ES-0184, ES-7018-MH, ES-7026-CMH thru ES-7031-CMH, ES-7032-MH, ES-7033-CMH, ES-7034-CMH, ES-7035-CMH, ES-7036-CMH; b) Serial numbers: 82-3928, 82-3929, 82-3930, 82-3931, 82-3933, 82-3934, 82-3935, 82-3936, 82-3937, 82-3938, 82-3939, 82-3941, 82-3942, 82-3943, 82-7191-MH, 82-7197-MH, 82-7206-MH, 89-3490, 89-3494, 89-3495, 89-3499, 89-3501, 89-3504, 89-3508, 89-3509, 89-3511, 89-3512, 89-3513, 89-3514, 89-3515, 89-3520, 89-3522, 89-3524, 89-3529, 89-3530, 89-3533, 89-3538, 89-3543, 89-3544, 89-3545, 89-3546, 89-3548, 89-3549, 89-3552, 89-3553, 89-3554, 89-3555, 89-3557, 89-3558, 89-3559, 89-3560, 89-3561, 89-3562, 89-3565, 89-3567, 89-3568, 89-3569, 89-3570, 89-3571, 89-3572, 89-3573, 89-3574, 89-3578, 89-3579, 8S-3183, 8S-3200, 8S-3205, 8S-3207, 8S-3211-CH, 8S-3216, 8S-3222, 8S-3231, 8S-3243, 8S-3245, 8S-3246, 8S-3247, 8S-3248, 8S-3249, 8S-3253, 8S-3254, 8S-3255, 8S-3256-H, 8S-3257, 8S-3258-CH, 8S-3259, 8S-3260, 8S-3261, 8S-3262, 8S-3263, 8S-3264, 8S-3265, 8S-3266, 8S-3267, 8S-3268, 8S-3269-H, 8S-3270-H, 8S-3271-H, 8S-3272-H, 8S-3273-CH, 8S-3274-CH, 8S-3276, 8S-3279, 8S-3280, 8S-3281, 8S-3283, 8S-3285, 8S-3286, 8S-3287, 8S-3288-H, 8S-3289-H, 8S-3290, 8S-3291, 8S-3292, 8S-3294, 8S-3295, 8S-3296, 8S-3297, 8S-3301-H, 8S-3302, 8S-3305, 8S-3306, 8S-3307, 8S-3308, 8S-3309, 8S-3310-H, 8S-3311, 8S-3315, 8S-7230-CMH, 8S-7231-MH, 8S-7232-MH, 8S-7233-MH c) Serial Numbers: 7315PU5, 7372PU6, 7384PU1, 7385PU8, 7389PU0, 7390PU8, 7393PU2, 7398PU1, 7398PU1, 7399PU9, 7702PU4, 7720PU6, 7721PU4, 7724PU8, 7725PU5, 7726PU3, 7728PU9, 7729PU7, 7732PU1, 7733PU9, 7734PU7. 7747PU9 d) Serial numbers: 86-2102, 86-2133, 86-2137, 86-2138, 86-2139, 86-2140, 86-2143, 86-2145, 86-2146, 86-2147, 86-2148, 86-2149, 86-2150, 86-2151, 86-2152, 86-2153, 86-2154, 86-2155, 86-2156, 86-2157, 86-2158, 86-2159, 86-2160, 86-2161, 86-2162, 86-2163, 86-2164, 86-2165, 86-2166, 86-2167, 86-2168, 86-2169, 86-2170, 86-2171, 86-2172, 86-2173, 86-2174, 86-2175, 86-2176, 86-2177, 86-2178, 86-2179, 86-2180, 86-2181, 86-2182, 86-2183, 86-2184, 86-2185, 86-2186, 86-2187, 86-2188, 86-2189, 86-2190, 86-2191, 86-2192, 86-2193, 86-2194, 86-2195, 86-2196, 86-2197, 86-2198, 86-2199, 86-2200, 86-2201, 86-2202, 86-2203, 86-2204, 86-2205, 86-2206, 86-2207, 86-2208, 86-2209, 86-2210, 86-2211, 86-2212, 86-2213, 86-2214, 86-2215, 86-2216, 86-2217, 86-2218, 86-2219, 86-2220, 86-2221, 86-2222, 86-2223, 86-2224, 86-2225, 86-2226, 86-2227, 86-2228, 86-2229, 86-2230, 86-2231, 86-2232, 86-2233, 86-2234, 86-2235, 86-2236, 86-2237, 86-2238, 86-2239; e) Serial numbers: P4-0665-R, P4-0666-L, P4-0679-R, P4-0685-L, P4-0686-L, P4-0694-R, P4-0696-L, P4-0701-R, P4-0702-R, P4-0717-L, P4-0723-R, P4-0730-L, P6-0695-R, P6-0699-R, P6-0700-R, P6-0709-R, P6-0711-L, P6-0712-R, P6-0714-L, P6-0715-L, P6-0718-R, P6-0719-L, P6-0721-L, P6-0724-R, P6-0726-L MANUFACTURED & RECALLED BY GE OEC Medical Systems, Inc., Salt Lake City, UT QUANTITY 483 units (domestic), 92 units (Internationally) DISTRIBUTION Nationwide and Internationally REASON X-ray systems were not configured to display Air Kerma Rate and Cumulative Air Kerma. --------------------------------------------------------------------------- Route To ____________________________________ Status ______________________ PRODUCT Invacare Storm TDX Power Wheelchair, Models: # TDX3-PS, TDX3-SE-PS, TDX4-PS RECALL NUMBER # Z-0966-2007 CODE 06JE002273, 06JE002762, 06JE003580, 06JE003583, 06JE003584, 06JE003585, 06JE003597, 06JE003598, 06JE003880, 06JE003890, 06JE004170, 06JE004172, 06JE004178, 06JE004196, 06JE004632, 06JE004640, 06JE005420, 06JE005421, 06JE005864, 06JE005870, 06JE005871, 06JE005879, 06JE005885, 06JE006254, 06JE006277, 06JE006599, 06JE006603, 06JE006612, 06JE007087, 06JE007393, 06JE007396, 06JE007403, 06JE007408, 06JE007818, 06JE008028, 06JE008311, 06JE008322, 06JE008324, 06JE008329, 06JE008330, 06JE008332, 06JE008350, 06JE008670, 06JE008678, 06JE009028, 06JE009031, 06JE009039, 06JE009040, 06JE009042, 06JE009060, 06JE009062, 06JE009076, 06KE000147, 06KE000149, 06KE001924, 06KE001933, 06KE002243, 06KE002264, 06KE002265, 06KE002267, 06KE002270, 06KE002851, 06KE002853, 06KE002858, 06KE002862, 06KE003116, 06KE003379, 06KE003381, 06KE003386, 06KE003612, 06KE004451, 06KE004454, 06KE004455, 06KE004467, 06KE004854, 06KE005538, 06KE005826, 06KE006063, 06KE006065, 06KE006333, 06KE006613, 06KE006876, 06KE006877, 06KE006886, 06KE006894, 06KE007257, 06KE007282, 06KE007294, 06KE007450, 06KE007684, 06KE007686, 06KE007689, 06KE008610, 06KE008611, 06LE000170, 06LE000173 06LE001305, 06LE001313, 06LE001527, 06LE001694, 06LE001696, 06LE001697, 06LE001705, 06LE001998, 06LE002608, 06LE003258, 06LE003261, 06LE003267, 06LE003268, 06LE003462, 06LE003466, 06LE003987, 06LE004643, 06LE004650, 06LE004846, 06LE004857, 06LE005143, 06LE005144, 06LE005148, 06LE005152, 06LE005154, 06LE005732, 06LE005895, 06LE006012, 06LE006013, 06LE006024, 06LE006704, 06LE006707, 06LE006709, 06LE007018, 06LE007210, 06LE007358, 06LE007371, 06LE007379, 06LE007387, 06LE007393, 06LE007397, 06LE007403, 06LE007404, 07AE000983, 07AE001149, 07AE001180, 07AE001326, 07AE001327, 07AE001334, 07AE001594, 07AE001595, 07AE002009, 07AE002013, 07AE002223, 07AE002225, 07AE002229, 07AE002400, 07AE002404, 07AE002670, 07AE002683, 07AE002990, 07AE003522, 07AE003700, 07AE003712, 07AE003713, 07AE003716, 07AE004618, 07AE005103, 07AE005337, 07AE005339, 07AE005340, 07AE005341, 07AE005586, 07AE005593, 07AE005597, 07AE005886, 07AE005887, 07AE005895, 07AE006089, 07AE006303, 07AE006308, 07AE006314, 07AE006927, 07AE006930, 07AE007089, 07AE007090, 07AE007091, 07AE007092, 07AE007103, 07AE007105, 07AE007113, 07AE007114, 07AE007326, 07AE007327, 07AE007331, 07AE007334, 07AE007598, 07AE007606, 07AE007607, 07AE007611, 07AE007612, 07BE001073, 07BE001076, 07BE001077, 07BE001078, 07BE001082, 07BE001093, 07BE001303, 07BE001309, 07BE001310, 07BE001578, 07BE001585, 07BE001806, 07BE001810, 07BE002005, 07BE002014, 07BE002015, 07BE002253, 07BE002254, 07BE003336, 07BE003337, 07BE003569, 07BE003574, 07BE003582, 07BE003584, 7BE003585, 07BE004719, 07BE004907, 07BE004913, 07BE004916, 07BE006332 MANUFACTURED & RECALLED BY Invacare Corp., Elyria, OH QUANTITY 227 units DISTRIBUTION Nationwide and Canada REASON Software error may permit the chair to recline too far. --------------------------------------------------------------------------- Route To ____________________________________ Status ______________________ PRODUCT ACCELERATOR APS System Input/Output Module (IOM); List Number: 7L01-01, Clinical Laboratory Workstation RECALL NUMBER # Z-1041-2007 CODE LN 7L01-01 MANUFACTURER Inpeco Spa, Segrate, Italy RECALLED BY Abbott Laboratories, Inc., Irving, TX QUANTITY 1 unit DISTRIBUTION UT REASON Product's hinged lid can fall, if not fully opened as designed, representing a potential injury hazard to the operator. ---------------------------------------------------------------------------