NRAC Issue #1696 ADDENDUM August 26, 2008 NATIONAL RECALL ALERT CENTER - IMMEDIATE WARNING ALERT NOTIFICATION THE FOLLOWING HAVE BEEN RECALLED OR ARE SUBJECT TO FIELD CORRECTION THIS LISTING IS ISSUED BY - NATIONAL RECALL ALERT CENTER, WASHINGTON, D.C. --------------------------------------------------------------------------- Route To ____________________________________ Status ______________________ PRODUCT a) Implantable Cardioverter Defibrillator EPIC VR Tiered-therapy Cardioverter/Defibrillator, Model V-197 RECALL NUMBER # Z-1320-2008 PRODUCT b) Implantable Cardioverter Defibrillator EPIC DR Tiered-therapy Cardioverter/Defibrillator, Model V-235 RECALL NUMBER # Z-1321-2008 PRODUCT c) Implantable Cardioverter Defibrillator EPIC HF Tiered-therapy Cardioverter/defibrillator with biventricular stimulation, Model V-337 RECALL NUMBER # Z-1322-2008 PRODUCT d) Implantable Cardioverter Defibrillator EPIC HF Tiered-therapy Cardioverter/Defibrillator with Biventricular Stimulation, Model V-338 RECALL NUMBER # Z-1323-2008 PRODUCT e) Implantable Cardioverter Defibrillator EPIC HF Tiered-therapy Cardioverter/defibrillator with biventricular stimulation, Model V-339 RECALL NUMBER # Z-1324-2008 PRODUCT f) Implantable Cardioverter Defibrillator EPIC + VR Tiered-therapy Cardioverter/defibrillator, Model V-196 RECALL NUMBER # Z-1325-2008 PRODUCT g) Implantable Cardioverter Defibrillator EPIC DR Tiered-therapy Cardioverter/defibrillator, Model V-233 RECALL NUMBER # Z-1326-2008 PRODUCT h) Implantable Cardioverter Defibrillator EPIC + DR Tiered-therapy Cardioverter/defibrillator, Model V-236 RECALL NUMBER # Z-1327-2008 PRODUCT i) Implantable Cardioverter Defibrillator EPIC + DR Tiered-therapy Cardioverter/defibrillator, Model V-239 RECALL NUMBER # Z-1328-2008 PRODUCT j) Implantable Cardioverter Defibrillator EPIC + HF Tiered-therapy Cardioverter/defibrillator with biventricular stimulation, Model V-350 RECALL NUMBER # Z-1329-2008 PRODUCT k) Implantable Cardioverter Defibrillator EPIC II VR Tiered-therapy Cardioverter/defibrillator, Model V-158 RECALL NUMBER # Z-1330-2008 PRODUCT l) Implantable Cardioverter Defibrillator EPIC II DR Tiered-therapy Cardioverter/defibrillator, Model V-255 RECALL NUMBER # Z-1331-2008 PRODUCT m) Implantable Cardioverter Defibrillator EPIC II+ DR Tiered-therapy Cardioverter/defibrillator, Model V-258 RECALL NUMBER # Z-1332-2008 PRODUCT n) Implantable Cardioverter Defibrillator EPIC II HF Tiered-therapy Cardioverter/defibrillator with Biventricular Stimulation, Model V-355 RECALL NUMBER # Z-1333-2008 PRODUCT o) Implantable Cardioverter Defibrillator EPIC II+ HF Tiered-therapy Cardioverter/defibrillator with Biventricular Stimulation, Model V-357 RECALL NUMBER # Z-1334-2008 PRODUCT p) Implantable Cardioverter Defibrillator EPIC II+ HF Tiered-therapy Cardioverter/defibrillator with Biventricular Stimulation, Model V-356 RECALL NUMBER # Z-1335-2008 PRODUCT q) Implantable Cardioverter Defibrillator ATLAS + VR Tiered-therapy Cardioverter/defibrillator, Model V-193 RECALL NUMBER # Z-1336-2008 PRODUCT r) Implantable Cardioverter Defibrillator ATLAS DR Tiered-therapy Cardioverter/defibrillator, Model V-242 RECALL NUMBER # Z-1337-2008 PRODUCT s) Implantable Cardioverter Defibrillator ATLAS + DR Tiered-therapy Cardioverter/defibrillator, Model V-243 RECALL NUMBER # Z-1338-2008 PRODUCT t) Implantable Cardioverter Defibrillator ATLAS + HF Tiered-therapy Cardioverter/defibrillator with biventricular stimulation, Model V-341 RECALL NUMBER # Z-1339-2008 PRODUCT u) Implantable Cardioverter Defibrillator ATLAS + HF Tiered-therapy Cardioverter/defibrillator with biventricular stimulation, Model V-340 RECALL NUMBER # Z-1340-2008 PRODUCT v) Implantable Cardioverter Defibrillator ATLAS + HF Tiered-therapy Cardioverter/defibrillator with biventricular stimulation, Model V-343 RECALL NUMBER # Z-1341-2008 PRODUCT w) Implantable Cardioverter Defibrillator ATLAS II VR Tiered-therapy Cardioverter/defibrillator, Model V-168 RECALL NUMBER # Z-1342-2008 PRODUCT x) Implantable Cardioverter Defibrillator ATLAS II DR Tiered-therapy Cardioverter/defibrillator, Model V-265 RECALL NUMBER # Z-1343-2008 PRODUCT y) Implantable Cardioverter Defibrillator ATLAS II+ DR Tiered-therapy Cardioverter/defibrillator, Model V-268 RECALL NUMBER # Z-1344-2008 PRODUCT z) Implantable Cardioverter Defibrillator ATLAS II HF Tiered-therapy Cardioverter/defibrillator with biventricular stimulation, Model V-365 RECALL NUMBER # Z-1345-2008 PRODUCT aa) Implantable Cardioverter Defibrillator ATLAS II+ HF Tiered-therapy Cardioverter/defibrillator with biventricular stimulation, Model V-366 RECALL NUMBER # Z-1346-2008 PRODUCT bb) Implantable Cardioverter Defibrillator ATLAS II+ HF Tiered-therapy Cardioverter/defibrillator with biventricular stimulation, Model V-367 RECALL NUMBER # Z-1347-2008 CODE All serial numbers MANUFACTURED & RECALLED BY St Jude Medical CRMD, Sylmar, CA QUANTITY Over 143,000 defibrillators DISTRIBUTION Nationwide and Internationally REASON A condition that could lead to a ventricular sensing anomaly in Epic and Atlas family of implantable Cardioverter Defibrillators (ICDs) has been identified. A loss of ventricular sensing would prevent the ICD from being able to detect an arrhythmia. If an arrhythmia occurred and the device was unable to detect it, then a patient would not receive potentially life saving therapy. --------------------------------------------------------------------------- Route To ____________________________________ Status ______________________ THE FOLLOWING IS AN UPDATE TO RECALL #1681 DATED 5/6/08, PAGE 2 PRODUCT a) Alcohol-Free Mouthwash, a yellow liquid in a 2 fl. oz. plastic bottle, 96 bottles per case, 4 fl. oz. (118 mL) plastic bottle, 24 bottles per case and 60 bottles per case, and in a 16 fl. oz. plastic bottle, 12 bottles per case; the mouthwash was distributed under the following labels, and in some cases may have been repackaged into hospital admission kits: 1) Hydrox Fresh Moment Alcohol Free Mouthwash, item #F0210 and I0210 (4 oz), and item D0212 (16 oz) 2) McKesson Medi-Pak Mouthwash, Reorder No. 23-I0210 (4 oz) and 23-D0212 (16 oz); 3) Cardinal Health Alcohol-Free Mouthwash, reorder AG-210 (4 oz) and AG-219 (2 oz) RECALL NUMBER # D-293-2008 PRODUCT b) Alcohol-Free Mouthwash, a blue liquid in a 4 fl. oz. (118 mL) plastic bottle, 60 bottles per case, and in a 32 fl. oz. plastic bottle, 12 bottles per case; the mouthwash was distributed under the following labels, and in some cases may have been repackaged into hospital admission kits: 1) Hydrox Fresh Moment Alcohol Free Mouthwash, item #I0220 (4 oz) and D0224 (32 oz) 2) Careline Mouthwash Blue Alcohol Free, re-order 033-0040, UPC 6 90450 01029 4 3) Freshscent Alcohol-Free Mouthwash, reorder #FMW2 (2 oz) and FMW4 (4 oz), UPC 0 85317 00231 2 4) DawnMist Alcohol Free Mouth Rinse, reorder #MR02 (2 oz) and MR3350 (4 oz) 5) GS Select Mouthwash, and Evoke Alcohol Free Mouthwash, both labels are for 4 oz bottles with reorder #1958 6) Bob Barker Alcohol-Free Mouthwash, 4 oz, part #AFM4 7) Rensow Alcohol-Free Mouthwash, 4 oz., UPC 8 27912 06379 0, Re-Order #601-510 8) Medline Alcohol Free SparkleFresh Mouthwash, Reorder MDS095029 (2 oz) and MDS095030 (4 oz) RECALL NUMBER # D-294-2008 PRODUCT c) Mouthwash with 2.5% Alcohol, a yellow liquid in a 4 oz. (118 mL) plastic bottle, 60 bottles per case; the mouthwash was distributed under the following labels: 1) Hydrox Fresh Moment Mouthwash and Gargle, item #I5200 2) McKesson Medi-Pak Mouthwash, Reorder No. 23-I5200 3) Medline SparkleFresh Mouthwash, REF MDS095040 RECALL NUMBER # D-295-2008 CODE a) 1) All lots 2) Lots 22862, 22864, 22979, 22995, 23053, 23056, 23267, 23272, 23418, 23481, 23488, 23558, 23581, 23754, 23763, 23829, 23837, 23916, 23918, 24047, 24096, 24194, 24212, 26265, 24279, 24268, 24350, 24476, 24566, 24637, 24702, 24715, 24847, 24875, 24921, 24950, 24989, 25075, 25103, 25233, 25286, 25339, 25548, 25552, 25554, 25616, 25642, 25793, 25936, 25966, 26005, 26045, 26048, 26049, 26174, 26214, 26223, 26240, 26488, 26507, 26511, 26512; Lots 22995, 23481, 24397, 24566, 24702, 25642, 26045, 26335, 26547 3) Lots 22818, 22864, 22876, 22877, 22925, 22926, 22936, 22981, 22996, 23006, 23013, 23014, 23046, 23104, 23110, 23114, 23164, 23176, 23184, 23215, 23219, 23236, 23304, 23307, 23313, 23351, 23353, 23358, 23359, 23394, 23424, 23425, 23443, 23444, 23500, 23523, 23535, 23546, 23552, 23584, 23700, 23706, 23754, 23941, 23965, 23996, 24035, 24046, 24047, 24124, 24128, 24178, 24181, 24194, 24260, 24261, 24268, 24325, 24326, 24365, 24386, 24389, 24460, 24465, 24466, 24537, 24540, 24590, 24599, 24660, 24661, 24698, 24701, 24713, 24734, 24751, 24753, 24756, 24779, 24781, 24798, 24817, 24828, 24888, 24903, 24954, 24969, 25001, 25008, 25012, 25044, 25084, 25086, 25090, 25096, 25101, 25149, 25193, 25198, 25199, 25204, 25253, 25299, 25300, 25301, 25305, 25335, 25363, 25406, 25409, 25416, 25478, 25479, 25481, 25515, 25522, 25554, 25578, 25581, 25594, 25627, 25666, 25681, 25686, 25688, 25729, 25732, 25738, 25789, 25791, 25797, 25836, 25840, 25875, 25877, 25899, 25910, 25949, 25966, 25967, 25968, 25997, 26004, 26005, 26021, 26025, 26037, 26039, 26041, 26097, 26099, 26102, 26115, 26121, 26144, 26194, 26219, 26220, 26228, 26230, 26233, 26254, 26272, 26282, 26324, 26326, 26330, 26380, 26383, 26431, 26488, 26495, 26497, 26534, 26547, 26556; reorder AG-219 - lots 22818, 22936, 23176, 23394, 23500, 23700, 23965, 24072, 24602, 24954, 25090, 25301, 25457, 25666, 25797, 26160, 26324 b) 1) All lots 2) Lots 22871, 22873, 22985, 23068, 23145, 23158, 23246, 23315, 23342, 23380, 23453, 23530, 23780, 23824, 24150, 24230, 24299, 24302, 24369, 24378, 24398, 24435, 24648, 24742, 24803, 24882, 24885, 24918, 25140, 25356, 25372, 25455, 25465, 25773, 26148, 26150 3) Lots 23621, 23846, 23973, 24790, 25713, 25939, 26451; Lots 23621, 23843, 24006, 24069, 24070, 24340, 24544, 24634, 24639, 24800, 24811, 25021, 25027, 25177, 25186, 25463, 25465, 25472, 25571, 25739, 25868, 25976, 25977, 26111, 26119, 26265, 26359, 26361, 26407 4) Lots 23391, 23404, 23501, 23514, 23973, 24108, 24312, 24534, 24606, 24851, 24952, 25038, 25135, 25463, 25572, 25713, 25802, 25939, 26083, 26298, 26396, Lots 22826, 22831, 22832, 23077, 23084, 23202, 23203, 23213, 23228, 23234, 23278, 23286, 23360, 23361, 23373, 23379, 23404, 23407, 23416, 23459, 23461, 23473, 23489, 23559, 23567, 23568, 23669, 23672, 23682, 23801, 23802, 23803, 23861, 23863, 23866, 23961, 23974, 23975, 23999, 24000, 24042, 24044, 24070, 24099, 24113, 24121, 24123, 24333, 24337, 24492, 24495, 24510, 24513, 24515, 24518, 24528, 24577, 24578, 24614, 24616, 24666, 24669, 24859, 24863, 24926, 24938, 24978, 24979, 24983, 24990, 24991, 25027, 25031, 25038, 25042, 25055, 25064, 25067, 25119, 25122, 25134, 25135, 25144, 25167, 25171, 25177, 25315, 25320, 25323, 25372, 25386, 25419, 25421, 25423, 25434, 25444, 25446, 25448, 25453, 25455, 25585, 25588, 25699, 25706, 25707, 25709, 25713, 25816, 25818, 25909, 25916, 25929, 25931, 25939, 25946, 25959, 25971, 25977, 25978, 25982, 25986, 25991, 26073, 26077, 26083, 26111, 26164, 26167, 26183, 26185, 26196, 26239, 26241, 26244, 26248, 26287, 26290, 26291, 26295, 26298, 26352, 26359, 26372, 26377, 26379, 26395, 26422, 26424, 26426, 26451, 26454, 26457, 26480, 26500 5) Lots 23029, 23041, 23227, 23286, 23287, 23514, 23516, 23880, 23980, 24094, 24164, 24310, 24470, 24546, 24646, 24763, 24872, 24998, 25200, 25328, 25388, 25483, 25575, 25655, 25658, 25739, 25742, 25868, 25931, 25982, 25986, 26008, 26149, 26267, 26396, 26433 6) Lots 24544, 26189, 26342, 26287, 24837, 24909, 25100, 25142, 25689, 26073, 26189, 26287, 26342 7) Lots 25589, 25655, 25658, 25914 8) Lots 23074, 23296, 23391, 23576, 23689, 23846, 23973, 24108, 24312, 24416, 24534, 24606, 24790, 24973, 25231, 25572, 25713, 26442, 26443, 26451, 26461, 26465, 26467, 26500, 26502, 26529, 26544; lots 22821, 22838, 22845, 22846, 22857, 22873, 22968, 22969, 22978, 22982, 23018, 23061, 23062, 23084, 23107, 23108, 23140, 23158, 23167, 23244, 23248, 23249, 23294, 23329, 23334, 23338, 23427, 23433, 23434, 23437, 23462, 23497, 23506, 23517, 23524, 23609, 23682, 23723, 23733, 23736, 23737, 23747, 23771, 23782, 23802, 23820, 23866, 23881, 23882, 23927, 23930, 23944, 23952, 23959, 24000, 24006, 24021, 24025, 24027, 24052, 24078, 24123, 24142, 24151, 24166, 24204, 24206, 24242, 24244, 24258, 24270, 24279, 24309, 24310, 24335, 24381, 24382, 24398, 24422, 24426, 24439, 24478, 24489, 24573, 24575, 24613, 24623, 24643, 24663, 24675, 24676, 24683, 24693, 24708, 24709, 24767, 24770, 24772, 24897, 24941, 25032, 25165, 25218, 25266, 25268, 25352, 25375, 25388, 25392, 25405, 25487, 25512, 25569, 25571, 25589, 25601, 25629, 25721, 25727, 24416, 26442, 26443, 26451, 26461, 26465, 26467, 26500, 26502, 26529, 26544 c) 1) All lots 2) Lots 22962, 23771, 23927, 24381, 24870, 25121, 25468, 25661, 26138, 26365 3) - 22855, 22962, 24870, 25121, 25468 MANUFACTURED & RECALLED BY Hydrox Chemical Co., Elgin, IL QUANTITY 60,000,000 bottles estimated DISTRIBUTION Nationwide REASON CGMP Deviations. The mouthwash was manufactured under conditions where by it may be contaminated with the bacteria Burkholderia cepacia. ---------------------------------------------------------------------------