NRAC Issue #1650 ADDENDUM October 2, 2007 --------------------------------------------------------------------------- Route To ____________________________________ Status ______________________ PRODUCT a) Nuclear medicine systems: Gemini 16, Model 4535 679 28961. Gemini GXL, Models # 4535 679 71891, #4535 679 75681, #4535 679 75691. Precedence, Model #2169 -3000A, #2169-3001A, #2169-3002A, and 2169-3003A. PET/CT Computed tomography systems RECALL NUMBER # Z-0013-2007; PRODUCT b) Brilliance(a) CT 6 slice, Model #4535 670 73191. Brilliance(a) CT 10 Slice, Model 4535 670 73181. Brilliance 16 Slice, Model #4535 670 78851. Brilliance CT 16 Power, Model #4535 670 23331. Brilliance CT 40 Slice Model #4550 110 04011. Brilliance CT Big Bore, Model #4535 670 88051. Computed tomography systems. RECALL NUMBER # Z-0014-2007 CODE a) Serial #s: 4034-4100, 4102, 4103, 1041 b) Serial #s: 30035; 40022; 5059, 50027, 50017; 6011, 6095, 6118, 60006; 9145, 9036, 9115, 9089, 9042, 90061, 90109, 90072, 90050, 90150, 7022 MANUFACTURED & RECALLED BY Philips Medical Systems (Cleveland), Inc., Cleveland, OH QUANTITY 90 devices DISTRIBUTION Nationwide and Internationally REASON A potential anomaly was identified on the CT subsystem, which could result in the radiation dose being different than the calculated dose reported to the operator. --------------------------------------------------------------------------- Route To ____________________________________ Status ______________________ PRODUCT a) Level 1 Normothermic IV Administration Sets, Disposable Sets: (D-60HL / DI-60HL Maximum normothermic flow rate: 500 mL/min; Disposable D-50 / DI-50 Maximum normothermic flow rate: 300 mL/min; D-100 / DI-100 Maximum normothermic flow rate: 800 mL/min; D-300 / DI-300 Maximum normothermic flow rate: 1000 mL/min; D-70 Maximum Flow Rate 525ml/min RECALL NUMBER # B-1583-07 PRODUCT b) Level 1 Normothermic Irrigating Set IR-500, IR-600 & IRI 600 IRI 600B, IR-700, IR-40 RECALL NUMBER # B-1584-07 CODE a) and b) All lots prior to the Expiration Date of July 2011 or earlier and not labeled with "Helium tested" MANUFACTURED & RECALLED BY Smiths Medical ASD, Inc., Rockland, MA QUANTITY 900,000 units DISTRIBUTION Nationwide and Internationally REASON Heat exchanger may leak in the inner lumen contaminating the blood/solutions being infused or the recirculating solution. --------------------------------------------------------------------------- Route To ____________________________________ Status ______________________ PRODUCT Software used by Blood Collection Centers and Blood Banks for donor screening RECALL NUMBER # B-1556-07 CODE Product Title: Blood Bank Control System Funtion/File/Callable: 087 Title: Donor Room Management Release: 5.0, 5.1, 5.2, 5.2.1, 5.2.2, and 5.3 (POD0001) DPP #: 4012E MANUFACTURED & RECALLED BY Blood Bank Computer Systems, Inc., Auburn, WA QUANTITY 193 CD's DISTRIBUTION Nationwide REASON Software, containing a glitch or defect related to donor deferral, was distributed. --------------------------------------------------------------------------- Route To ____________________________________ Status ______________________ PRODUCT Ampilink Software versions 1.1, 1.3, 1.4, 2.41 and 2.42 [COBAS AmpliPrep/COBAS Amplicor HIV-1 Monitor v1.5 test; COBAS Amplicor HIV-1 Monitor test v1.5; COBAS AmpliScreen HBV Test; COBAS AmpliScreen HCV Test, version 2; COBAS AmpliScreen HIV-1 Test, version 1.5 RECALL NUMBER # B-1554-07 CODE Catalog number 03309401018; working probe suspension/SM PS1-SM4; Working substrate SB3-SB; Catalog number 03155935018; working Probe Suspension/IM PS1-IM4; Working substrate SB3-SB; Catalog number 03599779190 Working Substrate SB3-SB; Catalog number 03302563018, Working Substrate SB3-SB; Catalog number 03322114018, Working Substrate SB3-SB MANUFACTURER Roche Instrument Center AG, Rotkreuz, Switzerland RECALLED BY Roche Molecular Systems, Inc., Somerville, NJ QUANTITY 5,806 units DISTRIBUTION Nationwide and Internationally REASON For select COBAS AMPLICOR tests run on the COBAS AMPLILINK software, a discrepancy has been identified between the onboard working reagent stability information reported by AMPLILINK Software (versions 1.1, 1.3, 1.4, and 2.41) and the stability information provided in the test kit package inserts/method manual. --------------------------------------------------------------------------- Route To ____________________________________ Status ______________________ PRODUCT EstroGel(r) 0.06% (estradiol gel), 24 gram multiple dose pump packaged in papercard carton labeled in part *Physician Sample * For Topical Use Only * Metered-dose pump capable of delivering fourteen 1.25 gram doses RECALL NUMBER # D-982-2007 CODE Lot 3136 Expiration September 2009 MANUFACTURER Laboratories Besins Iscovesco, Montrouge Cedex, France RECALLED BY Ascend Therapeutics, Inc., Herndon, VA QUANTITY 27,351 units DISTRIBUTION Nationwide REASON Mislabeled. Product labeled with incorrect expiration date (September 2009 instead of September 2007) --------------------------------------------------------------------------- Route To ____________________________________ Status ______________________ PRODUCT Terbinafine Hydrochloride Tablets, USP, equivalent to 250 mg base, Rx only, 500 Tablets, NDC 24658-180-05 RECALL NUMBER # D-981-2007 CODE Lot I0707102 (Exp. 06/09) MANUFACTURED & RECALLED BY InvaGen Pharmaceuticals, Inc., Hauppauge, NY QUANTITY 343 bottles (500 tablets per bottle) DISTRIBUTION KY REASON Labeling: Terbinafine Hydrochloride Tablets, 250 mg, 500 count bottles, Lot I0707102, were incorrectly labeled as Terbinafine Hydrochloride Tablets, USP --------------------------------------------------------------------------- Route To ____________________________________ Status ______________________ PRODUCT Octreotide Acetate Injection, 500 mcg/mL (0.5 mg/mL); an Rx subcutaneous injection long-acting octapeptide with pharmacologic actions mimicking those of the natural hormone somatostatin; 1 mL single dose vial, 10 vials per carton; product number 370701, NDC 63323-377-01 RECALL NUMBER # D-975-2007 CODE Lot number 202500, expiration date 6/2009 MANUFACTURER Abraxis Pharmaceutical Products, Melrose Park, IL RECALLED BY Abraxis Pharmaceutical Products, Rosemont, IL QUANTITY 1,490 vials DISTRIBUTION Nationwide REASON There is an error on the vial label that incorrectly indicates the product concentration is 0.05 mg/mL octreotide acetate when the actual concentration is 0.5 mg/mL. --------------------------------------------------------------------------- Route To ____________________________________ Status ______________________ PRODUCT a) Panocaps MT 20 Capsules (Pancrelipase Delayed Release Capsules, USP) Rx Only, 100 Capsules, NDC 51991-408-01 RECALL NUMBER # D-978-2007 PRODUCT b) Ultracaps MT 20 Capsules (Pancrelipase Delayed Release Capsules, USP), 100 Capsules, Rx Only, NDC 51991-409-01 RECALL NUMBER # D-979-2007 PRODUCT c) Palcaps 10 Capsules (Pancrelipase Delayed Release Capsules, USP) Rx Only 100 Capsules, NDC 51991-410-01 RECALL NUMBER # D-980-2007 CODE a) PCC8eS001 b) PCC9eS001 (expires Apr 08), PCC9eS002 (expires Aug 08) c) PCC10eS001 (expires Feb 08), PCC10eS002 (expires Jul 08) PCC10eS003 (expires Sep 08) MANUFACTURER Yung Shin Pharmaceutical Industry, Ltd., Tachia, Taiwan, Republic Of China RECALLED BY Carlsbad Technology Inc., Carlsbad, CA QUANTITY 30,536 bottles DISTRIBUTION TN REASON Presence of Undeclared Color Additive; product capsule shells contain undeclared FD&C Yellow #5 and discrepancies between labeled inactive ingredients in the package inserts and the inactive ingredients contained in the products; Some product capsule shells also contain undeclared color additive FD&C Yellow #5. --------------------------------------------------------------------------- Route To ____________________________________ Status ______________________ PRODUCT a) Philips Bucky Diagnost X-Ray System RECALL NUMBER # Z-0907-2007 PRODUCT b) Philips Digital Diagnost X-Ray system RECALL NUMBER # Z-0908-2007 PRODUCT c) Philips Easy Diagnost X-Ray System RECALL NUMBER # Z-0909-2007 PRODUCT d) Philips Easy Diagnost Eleva RECALL NUMBER # Z-0910-2007 PRODUCT e) Philips Omni Diagnost Eleva RECALL NUMBER # Z-0911-2007 PRODUCT f) Philips Multi Diagnost Eleva RECALL NUMBER # Z-0912-2007 CODE a) Site numbers 5024, 5175, 6135, 6143, 6181, 6228, 6717, 6740, 6759, 6773, 6786, 6797, 6798, 6810, 6826, 6836, 6843, 6857, 6858, 6859, 6864, 6866, 6873, 6883, 6884, 6885, 6888, 6889, 6893, 6903, 6904, 6920, 6925, 6932, 6936, 6954, 6958, 6959, 6964, 6973, 6974, 6982, 6988, 6989, 6992, 10029, 10033, 10066, 10145, 10417, 10419, 10429, 10434, 10461, 10477, 10481, 10498, 10499, 13012, 13028, 13032, 13034, 13122, 13125, 13131, 13146, 13159, 13175, 13198, 13216, 13224, 13225, 13243, 13244, 13246, 13247, 13248, 13249, 13250, 13251, 13252, 13254, 13256, 13278, 13279, 13295, 13611, 13613, 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539023, 539024, 539025, 539026, 539027, 539028, 539029, 539039, 539091, 539092, 539093, 539163, 539164, 539173, 539182, 539620, 539631, 539724, 539725, 539863, 539881, 540011, 540028, 540055, 540081, 540087, 540096, 540097, 540098, 540135, 540157, 540158, 540164, 540175, 540178, 540200, 540216, 540260, 540262, 540268, 540366, 540431, 540446, 540467, 540473, 540501, 540502, 540503, 540506, 540762, 540858, 540970, 541064, 541068, 541089, 541175, 541179, 541242, 541243, 541244, 541264, 541270, 541323, 541327, 541351, 541497, 541514, 541536, 541586, 541644, 541692, 541733, 541744, 541764, 541837, 541914, X0101, X0389, X0568, X0715, X0971, X0976, X1040, X1070, X1143, X1156, X1157, X1182, X1183, X1195, X1196, X1200, X1208, X1209, X1211, X1212, X1217, X1220, X1225, X1226, X1265, X1276, X1285, X1291, X1292, X1303, X1311, X1331, X1332, X1334, X1336, X1337, X1359, X1360, X1361, X1400, X1406, X1415, X1416, X1421, X1422, X1423, X1427, X1470, X1560, X1597, X1610, X1651, X1652, X1658, X1660, X1667, X1682, X1701, X1702, X1727, X1728, X1748, X1754, X1773 b) Site numbers 103982, 104073, 105158, 105629, 504343, 505773 c) Site numbers: 6901, 6961, 6983, 6987, 10000, 10002, 10006, 10178, 10392, 10393, 10406, 10410, 10418, 10435, 10493, 13173, 13178, 13195, 13215, 13245, 13257, 13283, 13284, 13293, 13877, 13880, 13895, 13908, 13956, 13968, 13969, 13970, 13972, 13984, 13999, 14070, 14169, 14177, 26140, 26154, 26157, 26211, 26212, 26213, 26275, 38086, 38091, 38106, 38120, 38141, 38142, 38149, 38195, 38196, 38207, 38268, 38279, 38314, 38318, 38361, 38417, 38423, 38424, 38434, 38505, 38528, 38529, 38539, 38541, 38555, 38559, 38584, 38591, 38607, 38608, 38625, 38626, 38634, 38656, 38679, 38689, 38692, 38693, 38695, 38712, 38743, 38745, 38914, 38940, 38958, 38972, 38977, 38978, 38988, 40930, 40936, 40937, 40973, 41035, 41040, 41063, 41096, 41098, 41099, 41105, 41107, 41120, 41121, 41131, 41135, 41235, 41236, 41237, 41238, 41284, 41286, 41352, 41420, 41435, 41463, 41465, 41466, 41468, 44804, 44805, 44806, 44983, 45029, 45070, 45091, 45092, 50220, 50221, 50230, 50322, 50323, 50427, 50446, 50447, 52450, 52456, 52491, 59569, 59634, 59652, 59661, 59666, 62663, 62664, 62797, 62802, 62838, 62868, 62888, 62889, 62934, 62973, 62987, 62994, 62996, 62997, 73858, 76192, 76216, 76355, 76356, 76357, 76371, 76372, 76379, 76381, 76382, 76391, 76403, 76439, 76456, 76495, 76578, 76763, 76805, 76827, 76829, 76837, 76838, 76843, 76844, 76874, 76925, 76940, 76957, 76958, 76959, 76960, 76965, 76967, 76973, 76982, 80318, 80319, 80339, 82503, 82515, 82516, 82561, 82570, 82571, 82613, 82630, 82646, 82656, 82674, 82675, 82712, 82720, 82722, 82726, 82728, 82805, 82809, 82831, 82834, 82918, 82920, 82942, 82943, 82949, 82954, 83001, 83007, 83031, 83074, 83083, 83308, 83319, 83369, 83370, 83646, 83648, 83651, 83698, 83909, 83936, 83943, 83944, 83947, 84420, 84434, 84459, 84460, 84461, 84703, 84704, 84851, 84857, 84858, 84889, 84893, 84895, 84928, 84931, 84936, 84938, 84939, 84949, 84963, 84964, 85029, 85030, 85037, 85109, 85117, 85147, 85148, 85149, 85161, 85166, 85167, 85168, 85184, 85402, 85403, 85405, 85437, 85438, 85464, 85465, 85467, 85484, 85486, 85487, 85492, 85493, 85494, 85683, 86015, 86059, 86060, 86070, 86071, 86078, 86140, 86213, 86215, 86216, 86221, 86226, 86228, 86229, 86232, 86309, 86344, 86358, 86359, 86384, 86386, 86387, 86389, 86391, 86394, 86395, 86397, 86400, 86403, 86543, 86547, 86579, 86600, 86601, 86606, 86607, 86611, 86613, 86618, 86619, 86623, 86624, 86901, 86903, 86938, 86939, 86942, 86964, 86966, 86970, 86976, 86979, 86980, 87005, 87016, 87017, 87031, 87045, 87046, 87050, 87051, 87079, 87136, 87137, 87138, 87142, 87169, 87175, 87177, 87178, 87196, 87313, 87320, 87333, 87363, 87510, 87520, 87601, 87609, 87610, 100428, 100438, 100443, 100457, 100481, 100489, 100495, 100518, 100556, 100557, 100604, 100605, 100614, 100615, 100618, 100676, 100677, 100698, 100727, 100770, 100818, 100834, 100835, 100838, 100848, 100855, 100867, 100876, 100882, 100883, 100947, 100957, 101039, 101041, 101054, 101076, 101079, 101080, 101132, 101133, 101134, 101141, 101142, 101143, 101144, 101145, 101147, 101148, 101149, 101161, 101191, 101204, 101212, 101240, 101555, 101558, 101563, 101569, 101586, 101643, 101837, 101871, 101872, 101935, 101936, 101937, 101955, 101958, 101959, 101960, 102099, 102107, 102132, 102163, 102168, 102169, 102170, 102174, 102245, 102337, 102338, 102339, 102341, 102342, 102372, 102376, 102384, 102385, 102387, 102388, 102445, 102462, 102466, 102491, 102541, 102552, 102559, 102567, 102585, 102586, 102587, 102590, 102591, 102606, 102608, 102609, 102622, 102630, 102634, 102647, 102700, 102701, 102794, 102839, 102876, 102893, 102903, 102917, 102918, 102921, 102922, 102925, 103007, 103008, 103037, 103057, 103115, 103120, 103121, 103146, 103163, 103180, 103184, 103185, 103200, 103204, 103252, 103260, 103276, 103279, 103284, 103310, 103337, 103387, 103421, 103422, 103424, 103427, 103496, 103497, 103504, 103517, 103595, 103597, 103606, 103653, 103724, 103730, 103785, 103786, 103876, 103883, 103895, 103917, 103943, 103948, 103963, 103977, 104010, 104013, 104051, 104059, 104071, 104113, 104135, 104153, 104162, 104164, 104165, 104181, 104182, 104204, 104205, 104268, 104283, 104339, 104404, 104471, 104508, 104629, 104794, 104801, 104842, 104854, 104855, 104881, 104893, 104931, 105109, 105155, 105202, 105238, 105242, 105295, 105337, 105414, 105649, 105696, 105769, 250043, 250069, 250092, 250139, 250313, 250679, 500012, 504137, 504329, 504882, 505056, 505640, 506168, 506171, 519562, 519766, 519776, 519826, 520262, 520279, 520280, 521003, 530692, 532044, 534057, 534433, 534873, 535262, X1027, X1041, X1055, X1056, X1089, X1136, X1140, X1141, X1142, X1153, X1165, X1166, X1180, X1181, X1194, X1201, X1229, X1230, X1234, X1264, X1266, X1290, X1295, X1299, X1304, X1320, X1338, X1362, X1363, X1399, X1405, X1417, X1446, X1449, X1467, X1469, X1501, X1502, X1504, X1507, X1510, X1515, X1521, X1543, X1561, X1565, X1568, X1569, X1572, X1573, X1632, X1640, X1644, X1653, X1671, X1681, X1705, X1706, X1713, X1749, X1752, X1764, X1769 d) Site numbers 102549, 102551, 103130, 103515, 103522, 103523, 103666, 104078, 104614, 104812, 105482, 105589, 105678, 105775, 105777, 500003, 500032, 504642, 504643, 504803, 504804, 504879, 504941, 504962, 504966, 505062, 505063, 505104, 505255, 505349, 505539, 505540, 505606, 505806, 505871, 505926, 506117, 506199, 506205, 506208, 506210, 506231, 506233, 506248, 506249, 506250, 506251, 506275, 506276, 506277, 506278, 506281, 506305, 506554, 506828, 506844, 506845, 519117, 519121, 519122, 519128, 519152, 519773, 519879, 519900, 520182, 520183, 520209, 520300, 520301, 520516, 520707, 520798, 520806, 521135, 521153, 521606, 521654, 521658, 521869, 521942, 522015, 522193, 522271, 522399, 522401, 522443, 522470, 522480, 530573, 530607, 530795, 530797, 530798, 531769, 531832, 531857, 531860, 532069, 532107, 532137, 532139, 532157, 532170, 532174, 532177, 532360, 532397, 532398, 532426, 532471, 532477, 532479, 532766, 532779, 532842, 532971, 532978, 533234, 533240, 533243, 533313, 533389, 533396, 533451, 533470, 533490, 533491, 533528, 533558, 533562, 533565, 533566, 533574, 533766, 533770, 533771, 533867, 533898, 533914, 533918, 533968, 534207, 534419, 534434, 534596, 534599, 534600, 534615, 534644, 534647, 534675, 534677, 534694, 534782, 534803, 534805, 534815, 534822, 534824, 534850, 534867, 534945, 535021, 535233, 535255, 535365, 535378, 535382, 535436, 535437, 535500, 535613, 535757, 535765, 535771, 535785, 535908, 535995, 536011, 536051, 536081, 536082, 536179, 536200, 536394, 536458, 536522, 536636, 536637, 536687, 536765, 536840, 536914, 536933, 536938, 536941, 536973, 536984, 536985, 536994, 537013, 537087, 537091, 537179, 537186, 537492, 537518, 537571, 537654, 537689, 537761, 537796, 537803, 537863, 537945, 537946, 537967, 537970, 537971, 538237, 538328, 538351, 538407, 538451, 538458, 538462, 538477, 538480, 538519, 538759, 538812, 538866, 538891, 538901, 539040, 539095, 539101, 539103, 539237, 539291, 539310, 539339, 539411, 539419, 539488, 539501, 539519, 539527, 539557, 539590, 539683, 539785, 540022, 540163, 540187, 540361, 540380, 540445, 540457, 540459, 540624, 540788, 540810, 541011, 541054, 541063, 541075, 541078, 541083, 541093, 541348, 541402, 541494, 541535, 541614, 541694, 541721, 541803, 541838, 541850, 541872, 541884 e) Site numbers 520020, 521648, 522220, 533112, 533314, 533471, 533530, 535118, 535257, 535924, 539106, 540860, 541490 f) Site numbers 102666, 104083, 104530, 105193, 105194, 105394, 504340, 504341, 505039, 505345, 505346, 506155, 506236, 506247, 519574, 532087, 532140, 532151, 532213, 532703, 533312, 533473, 533559, 534247, 535714, 535767, 536019, 536091, 536146, 536720, 536935, 537083, 537669, 537787, 538440, 539457, 539598, 539990, 540252, 541263, 541474 MANUFACTURED & RECALLED BY Philips Medical Systems North America Co. Phillips, Bothell, WA QUANTITY 2,583 units DISTRIBUTION Nationwide REASON Units do not comply with the requirement to provide automatic beam limitation within +/- 3 degrees of horizontal, vertical, and perpendicular to the plane of the image receptor during radiographic procedures. --------------------------------------------------------------------------- 2