Class 2 Device Recall Altrua 2

• Date Initiated by Firm: June 03, 2021
• Date Posted: July 02, 2021
• Recall Status: Open, Classified
• Recall Number: Z-2001-2021
• Recall Event ID: 88087
• Product Classification: Implantable pulse generator, pacemaker (non-CRT) - Product Code LWP
• Product: Altrua 2 pacemaker, Models:; a) S701 ; b) S702; c) S722
• Code Information: a) S701, Serial Numbers: 100005, 100011, 100012, 100015, 100017, 100021, 100022, 100028, 100032, 100034, 100037, 100053, 100055, 100059, 100060, 100068, 100075, 100079, 100082, 100083, 100090, 100095, 100098, 100103, 100106, 100116, 100119, 100122, 100124, 100128, 100132, 100135, 100139, 100141, 100148, 100149, 100205, 100208, 100211, 100213, 100221, 100230, 100231, 100232, 100234, 100236, 100238, 100239, 100245, 100247, 100251, 100252, 100254, 100255, 100262, 100265, 100269, 100303, 100305, 100306, 100311, 100348, 100366, 100377, 100378, 100380, 100383, 100390, 100391, 100392, 100393, 100394, 100395, 100396, 100399, 100400, 100401, 100403, 100405, 100406, 700002, 700003, 700004, 700005, 700006, 700008, 700010, 700021, 700022, 700023, 700024, 700025, 700026, 700027, 700028, 700029, 700031, 700036, 700037, 700039, 700040, 700042, 700043, 700044, 700046, 700047, 700048, 700049, 700050, 700051, 700055, 700062, 700067, 700081, 700083, 700084, 700086, 700089, 700091, 700092, 700093, 700095, 700096, 700097, 700100, 700102, 700103, 700104, 700105, 700106, 700107, 700109, 700111, 700112, 700117, 700118, 700120, 700123, 700124, 700125, 700127, 700128, 700129, 700130, 700133, 700136, 700137, 700138, 700139, 700141, 700144, 700145, 700147, 700148, 700149, 700150, 700151, 700152, 700153, 700155, 700156, 700160, 700162, 700163, 700164, 700167, 700169, 700170, 700171, 700173, 700176, 700177, 700181, 700182, 700184, 700187, 700188, 700189, 700306, 700309, 700310, 700311, 700312, 700313, 700316, 700317, 700318, 700329, 700334, 700335, 700336, 700337, 700338, 700339, 700340, 700344, 700345, 700346, 700353, 700355, 700356, 700357, 700359, 700360, 700362, 700363, 700364, 700366, 700368, 700369, 700371, 700373, 700388, 700389, 700390, 700392, 700393, 700394, 700396, 700397, 700399, 700403, 700404, 700643, 700709, 700710, 700712, 700721, 700725, 700735, 700736, 700737, 700738, 700740, 700741, 700742, 700744, 700745, 700747, 700748, 700770, 700772, 700776, 700777, 700785, 700786, 700788, 700791, 700793, 700795, 700796, 700797, 700799, 700801, 700802, 700804, 700805, 700818, 700823, 700835, 700836, 700848, 700849, 700855, 700856, 700860, 700861, 700864, 700865, 700867, 700871, 700873, 700874, 700879, 700881, 700887, 700898, 700912, 700917, 700931, 700932, 700935, 700937, 700938, 700939, 700950, 700951, 700952, 700955, 700958, 700960, 700961, 700962, 700970, 700976, 700979, 700989, 701007, 701008, 701012, 701021, 701026, 701029, 701032, 701033, 701038, 701042, 701051, 701053, 701055, 701059, 701061, 701062, 701063, 701071, 701073, 701074, 701077, 701078, 701080, 701081, 701082, 701091, 701097, 701098, 701099, 701100, 701106, 701132, 701136, 701137, 701138, 701139, 701141, 701144, 701146, 701151, 701156, 701157, 701161, 701167, 701172, 701178, 702097, 702104, 702131, 702138, 702165, 702167, 702220, 702223, 702298, 702299, 702300, 702301, 702304, 702318, 702320, 702321, 702322, 702323, 702325, 702327, 704574, 704583, 704590, 704593, 704594, 704598, 704599, 704600, 704631, 704637, 704639, 704642, 100002, 100003, 100004, 100007, 100008, 100009, 100010, 100013, 100014, 100016, 100018, 100019, 100020, 100023, 100025, 100026, 100027, 100030, 100031, 100033, 100035, 100036, 100038, 100039, 100040, 100041, 100042, 100043, 100044, 100045, 100046, 100047, 100048, 100049, 100050, 100051, 100052, 100054, 100056, 100057, 100058, 100061, 100062, 100063, 100064, 100065, 100066, 100067, 100069, 100070, 100071, 100072, 100073, 100076, 100077, 100078, 100081, 100084, 100085, 100086, 100087, 100088, 100091, 100092, 100093, 100094, 100096, 100097, 100099, 100100, 100101, 100102, 100104, 100109, 100111, 100112, 100114, 100115, 100117, 100118, 100120, 100121, 100123, 100126, 100127, 100129, 100130, 100131, 100133, 100136, 100137, 100138, 100140, 100142, 100143, 100144, 100145, 100146, 100147, 100150, 100151, 100152, 100153, 100154, 100155, 100156, 100158, 100159, 100160, 100161, 100162, 100163, 100164, 100165, 100166, 100167, 100168, 100169, 100170, 100171, 100172, 100173, 100174, 100175, 100176, 100177, 100178, 100179, 100180, 100181, 100182, 100183, 100185, 100186, 100187, 100188, 100189, 100190, 100191, 100192, 100193, 100195, 100196, 100197, 100198, 100200, 100201, 100202, 100203, 100206, 100210, 100212, 100214, 100215, 100216, 100218, 100219, 100220, 100222, 100224, 100225, 100228, 100229, 100235, 100237, 100240, 100241, 100242, 100243, 100244, 100246, 100248, 100249, 100250, 100257, 100259, 100260, 100263, 100266, 100267, 100268, 100270, 100271, 100272, 100275, 100278, 100279, 100280, 100282, 100283, 100284, 100285, 100286, 100287, 100288, 100289, 100290, 100291, 100292, 100294, 100295, 100296, 100298, 100300, 100301, 100302, 100307, 100308, 100310, 100312, 100314, 100315, 100316, 100317, 100318, 100321, 100342, 100349, 100353, 100354, 100355, 100356, 100357, 100358, 100359, 100360, 100361, 100362, 100364, 100365, 100367, 100368, 100369, 100370, 100371, 100372, 100373, 100374, 100375, 100376, 100379, 100381, 100382, 100384, 100385, 100386, 100387, 100388, 100389, 100397, 100402, 100404, 700001, 700030, 700032, 700033, 700034, 700035, 700041, 700045, 700052, 700053, 700054, 700056, 700057, 700058, 700059, 700060, 700063, 700065, 700066, 700068, 700069, 700070, 700071, 700072, 700073, 700074, 700075, 700077, 700078, 700079, 700080, 700082, 700085, 700087, 700088, 700090, 700094, 700098, 700099, 700101, 700108, 700110, 700113, 700114, 700115, 700116, 700119, 700121, 700126, 700131, 700132, 700134, 700135, 700142, 700143, 700146, 700157, 700158, 700159, 700165, 700166, 700168, 700172, 700174, 700178, 700179, 700180, 700191, 700304, 700305, 700330, 700331, 700332, 700333, 700341, 700342, 700343, 700351, 700352, 700354, 700358, 700365, 700367, 700370, 700374, 700387, 700391, 700395, 700398, 700400, 700401, 700402, 700634, 700639, 700640, 700641, 700642, 700659, 700660, 700661, 700662, 700663, 700664, 700665, 700666, 700667, 700668, 700669, 700711, 700713, 700714, 700715, 700716, 700719, 700720, 700722, 700723, 700724, 700739, 700749, 700750, 700763, 700764, 700765, 700766, 700767, 700768, 700769, 700771, 700773, 700774, 700775, 700778, 700787, 700789, 700790, 700792, 700794, 700798, 700800, 700803, 700819, 700820, 700821, 700822, 700824, 700825, 700826, 700827, 700828, 700829, 700830, 700831, 700832, 700833, 700837, 700838, 700839, 700840, 700841, 700842, 700843, 700844, 700845, 700846, 700847, 700850, 700857, 700858, 700859, 700862, 700863, 700866, 700868, 700869, 700870, 700872, 700875, 700876, 700877, 700878, 700880, 700882, 700883, 700884, 700885, 700886, 700899, 700900, 700901, 700902, 700903, 700904, 700905, 700906, 700907, 700908, 700909, 700910, 700911, 700913, 700914, 700915, 700916, 700918, 700919, 700920, 700921, 700922, 700923, 700924, 700925, 700926, 700927, 700928, 700929, 700930, 700933, 700934, 700936, 700940, 700948, 700949, 700953, 700954, 700956, 700957, 700959, 700963, 700964, 700965, 700966, 700967, 700968, 700971, 700972, 700973, 700977, 700978, 700981, 700982, 700983, 700990, 700991, 700992, 700993, 700994, 700995, 700996, 700997, 700998, 701005, 701006, 701009, 701010, 701011, 701013, 701014, 701015, 701016, 701017, 701018, 701022, 701023, 701024, 701025, 701027, 701028, 701030, 701031, 701034, 701035, 701036, 701037, 701039, 701040, 701041, 701049, 701050, 701052, 701054, 701056, 701057, 701058, 701060, 701064, 701065, 701066, 701067, 701068, 701069, 701070, 701072, 701075, 701076, 701079, 701083, 701084, 701085, 701086, 701089, 701090, 701093, 701094, 701095, 701096, 701109, 701120, 701121, 701130, 701131, 701133, 701134, 701135, 701140, 701142, 701143, 701145, 701147, 701148, 701149, 701150, 701152, 701153, 701154, 701155, 701159, 701160, 701162, 701163, 701164, 701165, 701166, 701168, 701169, 701170, 701171, 701173, 701174, 701175, 701176, 701177, 701179, 701180, 701181, 701182, 702127, 702128, 702129, 702130, 702132, 702133, 702134, 702135, 702136, 702137, 702139, 702140, 702141, 702163, 702164, 702166, 702170, 702171, 702172, 702179, 702180, 702191, 702192, 702193, 702194, 702219, 702221, 702222, 702296, 702297, 702302, 702303, 702319, 702326, 704566, 704567, 704568, 704569, 704570, 704571, 704572, 704573, 704575, 704582, 704584, 704585, 704586, 704587, 704588, 704589, 704591, 704592, 704595, 704596, 704597, 704601, 704602, 704603, 704604, 704606, 704607, 704608, 704609, 704610, 704611, 704628, 704629, 704630, 704633, 704634, 704635, 704636, 704638, 704640, 704641, 704643, 704644, 704645, 704646, 704647 b) S702, Serial Numbers: 100010, 100042, 100054, 100082, 100084, 100097, 100101, 100111, 100119, 100126, 100146, 100148, 100152, 100155, 100165, 100167, 100172, 100173, 100174, 100182, 100184, 100191, 100194, 100196, 100203, 100206, 100207, 100208, 100209, 100210, 100215, 100219, 100221, 100223, 100229, 100232, 100235, 100237, 100239, 100242, 100243, 100246, 100255, 100257, 100258, 100261, 100262, 100270, 100273, 100277, 100286, 100290, 100292, 100293, 100297, 100298, 100312, 100319, 100327, 100330, 100331, 100332, 100336, 100341, 100343, 100344, 100346, 100349, 100352, 100357, 100363, 100365, 100387, 100393, 100401, 100402, 100403, 100406, 100410, 100502, 100551, 100555, 100573, 100608, 100619, 100643, 100680, 100698, 100714, 100758, 100799, 100843, 100849, 100850, 100851, 100858, 100860, 100864, 100865, 100875, 100879, 100909, 100911, 100921, 100922, 100924, 700081, 700097, 700105, 700111, 700113, 700121, 700193, 700199, 700208, 700209, 700210, 700214, 700230, 700233, 700236, 700238, 700240, 700242, 700252, 700258, 700269, 700270, 700282, 700288, 700702, 700807, 700810, 700867, 700868, 700871, 700875, 700885, 700888, 700899, 700901, 700906, 700907, 700915, 700918, 700919, 700922, 700925, 700926, 700927, 700934, 700937, 700942, 700944, 700948, 700951, 700954, 700959, 700964, 700974, 700979, 700984, 700991, 700996, 701003, 701006, 701015, 701016, 701018, 701021, 701030, 701031, 701056, 701057, 701063, 701065, 701073, 701075, 701077, 701082, 701097, 701102, 701105, 701108, 701109, 701111, 701115, 701117, 701119, 701120, 701126, 701128, 701129, 701130, 701131, 701132, 701133, 701136, 701138, 701139, 701141, 701143, 701144, 701146, 701148, 701153, 701154, 701155, 701156, 701160, 701161, 701164, 701165, 701167, 701172, 701173, 701174, 701175, 701177, 701179, 701181, 701184, 701193, 701196, 701197, 701202, 701203, 701206, 701211, 701212, 701213, 701218, 701220, 701221, 701226, 701227, 701228, 701229, 701230, 701231, 701232, 701233, 701234, 701235, 701753, 703262, 703265, 703271, 703281, 703293, 703294, 703306, 703307, 703318, 703322, 100002, 100003, 100004, 100005, 100006, 100007, 100008, 100009, 100011, 100012, 100013, 100014, 100015, 100016, 100017, 100018, 100020, 100021, 100025, 100026, 100028, 100029, 100030, 100031, 100032, 100033, 100034, 100035, 100036, 100037, 100038, 100040, 100045, 100046, 100050, 100051, 100052, 100053, 100055, 100056, 100057, 100058, 100059, 100060, 100061, 100062, 100063, 100064, 100065, 100066, 100067, 100068, 100069, 100070, 100071, 100072, 100073, 100074, 100075, 100076, 100077, 100078, 100079, 100080, 100081, 100083, 100085, 100086, 100087, 100088, 100089, 100090, 100091, 100092, 100093, 100094, 100095, 100096, 100098, 100099, 100100, 100102, 100103, 100104, 100105, 100106, 100107, 100108, 100109, 100110, 100112, 100113, 100115, 100116, 100117, 100118, 100120, 100121, 100122, 100123, 100124, 100125, 100128, 100130, 100131, 100132, 100133, 100134, 100135, 100136, 100137, 100138, 100139, 100140, 100141, 100142, 100143, 100144, 100145, 100147, 100149, 100150, 100151, 100153, 100154, 100156, 100158, 100159, 100160, 100161, 100162, 100163, 100164, 100166, 100168, 100170, 100171, 100175, 100176, 100177, 100179, 100180, 100181, 100183, 100185, 100186, 100187, 100188, 100189, 100190, 100192, 100193, 100195, 100197, 100198, 100199, 100200, 100201, 100202, 100204, 100205, 100211, 100212, 100213, 100214, 100216, 100217, 100218, 100220, 100222, 100224, 100225, 100226, 100227, 100228, 100230, 100231, 100234, 100236, 100238, 100240, 100241, 100244, 100245, 100247, 100248, 100249, 100250, 100251, 100252, 100253, 100254, 100256, 100259, 100260, 100263, 100265, 100266, 100267, 100268, 100269, 100271, 100272, 100274, 100275, 100276, 100278, 100279, 100280, 100281, 100282, 100283, 100284, 100285, 100287, 100289, 100291, 100294, 100299, 100300, 100301, 100302, 100303, 100305, 100306, 100307, 100308, 100310, 100311, 100313, 100314, 100315, 100316, 100317, 100318, 100320, 100321, 100322, 100323, 100324, 100325, 100326, 100328, 100329, 100333, 100334, 100335, 100338, 100340, 100342, 100345, 100347, 100348, 100350, 100351, 100353, 100354, 100355, 100358, 100359, 100360, 100361, 100362, 100366, 100367, 100368, 100369, 100370, 100371, 100372, 100373, 100374, 100375, 100376, 100377, 100378, 100379, 100380, 100381, 100382, 100383, 100385, 100386, 100388, 100389, 100390, 100391, 100392, 100394, 100396, 100398, 100399, 100400, 100404, 100405, 100407, 100408, 100409, 100411, 100412, 100413, 100414, 100415, 100416, 100417, 100418, 100419, 100420, 100423, 100424, 100425, 100427, 100430, 100431, 100432, 100434, 100435, 100436, 100437, 100438, 100439, 100440, 100441, 100442, 100444, 100445, 100446, 100447, 100448, 100449, 100450, 100452, 100453, 100454, 100456, 100457, 100458, 100459, 100460, 100461, 100462, 100463, 100464, 100465, 100466, 100467, 100468, 100469, 100470, 100471, 100472, 100473, 100474, 100475, 100476, 100477, 100478, 100479, 100480, 100481, 100482, 100483, 100484, 100485, 100486, 100487, 100488, 100489, 100490, 100491, 100493, 100495, 100496, 100497, 100498, 100499, 100500, 100501, 100503, 100505, 100506, 100507, 100508, 100511, 100513, 100515, 100517, 100518, 100519, 100520, 100521, 100523, 100524, 100525, 100526, 100527, 100528, 100529, 100530, 100531, 100532, 100533, 100534, 100535, 100537, 100538, 100539, 100540, 100541, 100542, 100543, 100544, 100545, 100546, 100547, 100548, 100549, 100550, 100552, 100553, 100554, 100556, 100557, 100558, 100559, 100560, 100561, 100562, 100563, 100564, 100565, 100566, 100568, 100569, 100571, 100574, 100576, 100577, 100578, 100581, 100582, 100583, 100584, 100585, 100586, 100587, 100588, 100589, 100591, 100592, 100593, 100594, 100595, 100596, 100597, 100598, 100599, 100600, 100601, 100602, 100603, 100604, 100605, 100606, 100607, 100609, 100610, 100611, 100613, 100614, 100615, 100616, 100617, 100618, 100620, 100621, 100622, 100623, 100624, 100625, 100626, 100627, 100628, 100629, 100630, 100631, 100632, 100634, 100635, 100636, 100637, 100638, 100639, 100640, 100641, 100642, 100644, 100645, 100646, 100647, 100648, 100649, 100650, 100651, 100652, 100653, 100654, 100655, 100656, 100657, 100658, 100659, 100660, 100661, 100662, 100663, 100664, 100665, 100666, 100667, 100668, 100669, 100670, 100671, 100672, 100673, 100674, 100675, 100676, 100677, 100678, 100679, 100681, 100682, 100683, 100684, 100685, 100686, 100689, 100690, 100691, 100692, 100693, 100694, 100695, 100696, 100699, 100700, 100701, 100702, 100703, 100704, 100705, 100707, 100708, 100709, 100710, 100711, 100712, 100713, 100715, 100716, 100717, 100718, 100720, 100721, 100722, 100723, 100724, 100725, 100726, 100727, 100728, 100729, 100730, 100731, 100732, 100733, 100734, 100735, 100736, 100737, 100738, 100739, 100740, 100741, 100742, 100743, 100744, 100745, 100746, 100747, 100748, 100749, 100750, 100751, 100752, 100753, 100754, 100755, 100756, 100757, 100759, 100760, 100761, 100762, 100763, 100764, 100765, 100766, 100767, 100768, 100769, 100770, 100771, 100772, 100773, 100774, 100775, 100776, 100781, 100796, 100797, 100798, 100800, 100801, 100802, 100803, 100804, 100805, 100806, 100807, 100808, 100809, 100817, 100819, 100820, 100821, 100822, 100823, 100824, 100825, 100826, 100831, 100839, 100845, 100846, 100847, 100848, 100852, 100854, 100855, 100856, 100862, 100863, 100867, 100868, 100869, 100870, 100871, 100872, 100873, 100874, 100877, 100878, 100880, 100881, 100882, 100884, 100885, 100887, 100888, 100889, 100890, 100892, 100894, 100895, 100896, 100897, 100898, 100899, 100900, 100901, 100903, 100904, 100905, 100906, 100907, 100908, 100912, 100913, 100914, 100915, 100916, 100917, 100919, 100920, 100923, 100925, 100926, 100927, 100928, 100929, 100930, 100931, 100932, 100933, 100935, 100936, 100937, 100938, 100939, 100940, 100941, 100952, 100953, 100954, 100956, 100957, 100958, 100959, 100960, 100961, 700001, 700002, 700003, 700004, 700005, 700006, 700007, 700008, 700009, 700010, 700011, 700012, 700017, 700019, 700021, 700022, 700023, 700024, 700025, 700026, 700028, 700029, 700030, 700031, 700032, 700033, 700034, 700035, 700036, 700039, 700041, 700042, 700043, 700045, 700046, 700047, 700048, 700049, 700050, 700051, 700052, 700054, 700055, 700056, 700057, 700058, 700060, 700061, 700062, 700063, 700064, 700065, 700066, 700067, 700068, 700069, 700070, 700071, 700072, 700073, 700074, 700075, 700076, 700078, 700079, 700080, 700082, 700083, 700084, 700085, 700086, 700087, 700088, 700089, 700090, 700091, 700093, 700094, 700095, 700096, 700098, 700099, 700100, 700101, 700102, 700103, 700104, 700106, 700107, 700108, 700109, 700110, 700112, 700114, 700115, 700117, 700118, 700119, 700120, 700122, 700124, 700125, 700126, 700127, 700128, 700129, 700130, 700131, 700132, 700133, 700134, 700135, 700136, 700138, 700139, 700140, 700141, 700142, 700143, 700144, 700145, 700146, 700147, 700148, 700149, 700150, 700151, 700152, 700153, 700154, 700155, 700156, 700157, 700158, 700159, 700160, 700161, 700162, 700163, 700164, 700165, 700166, 700167, 700168, 700169, 700170, 700171, 700172, 700173, 700174, 700175, 700176, 700177, 700178, 700179, 700180, 700181, 700182, 700183, 700184, 700185, 700186, 700187, 700188, 700189, 700190, 700191, 700192, 700195, 700196, 700197, 700198, 700200, 700201, 700202, 700203, 700204, 700207, 700211, 700212, 700213, 700215, 700216, 700217, 700218, 700219, 700220, 700221, 700222, 700223, 700225, 700227, 700228, 700229, 700231, 700232, 700234, 700235, 700239, 700241, 700243, 700244, 700245, 700248, 700249, 700250, 700251, 700253, 700254, 700255, 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c) S722, Serial Numbers: 100002, 100006, 100008, 100011, 100012, 100014, 100015, 100020, 100022, 100025, 100026, 100030, 100032, 100035, 100036, 100037, 100038, 100039, 100041, 100046, 100048, 100052, 100053, 100057, 100059, 100060, 100061, 100064, 100066, 100067, 100068, 100070, 100071, 100072, 100073, 100075, 100076, 100077, 100080, 100081, 100084, 100086, 100088, 100090, 100091, 100092, 100094, 100096, 700001, 700004, 700005, 700006, 700008, 700009, 700011, 700014, 700032, 700033, 700034, 700035, 700037, 700039, 700040, 700042, 700043, 700045, 700046, 700049, 700052, 700053, 700054, 700055, 700057, 700059, 700060, 700061, 700062, 700064, 700065, 700068, 700069, 700070, 700071, 700075, 700082, 700084, 700085, 700086, 700087, 700091, 700094, 700095, 700098, 700100, 700102, 700104, 700107, 700108, 700109, 700113, 700128, 700130, 700131, 700132, 700138, 700141, 700142, 700143, 700145, 700150, 700151, 700155, 700157, 700159, 700160, 700162, 700164, 700165, 700166, 700168, 700169, 700181, 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• Recalling Firm/ Manufacturer: Boston Scientific Corporation; 4100 Hamline Ave N Bldg 3; Saint Paul MN 55112-5700
• For Additional Information Contact: United States Technical Services; 800-227-3422
• Manufacturer Reason for Recall: Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacitor to become electrically compromised over time resulting in accelerated battery depletion of the battery and associated progression of displayed battery depletion indicators.
• FDA Determined Cause: Nonconforming Material/Component
• Action: The firm began notifying its sales representatives on 06/02/2021 by email or hand delivery and followed with notifying the implanting/following physicians and centers on 06/03/2021 by letter. The letter explained the issue and provided recommendations for the physicians. Information is also posted on www.BostonScientific.com/advisory. Patient notification is done by the implanting/following physician.
• Quantity in Commerce: 2952 units
• Distribution: Worldwide distribution.
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.