CLASS II Device recall · Reported 26 Feb 2020 · FDA Enforcement Report

Disposable Aortic Punch, in the following sizes: a) recalled

Teleflex Medical is recalling Disposable Aortic Punch, in the following sizes: a). The recall was initiated on 13 Jan 2020 and the FDA has classified it as Class II.

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Lot, batch or date codesa) Teleflex Medical Disposable Aortic Punch, 2.8 mm, REF DP-28K Lot Numbers: 74A1501140, 74B1602364, 74E1700597, 74G1602599, 74H1900357, 74L1501549, 74A1601253, 74B1900832, 74E1800886, 74G1700636, 74J1501218, 74L1501977, 74A1601254, 74C1501113, 74E1802643, 74G1700637, 74J1501754, 74L1501978, 74A1602903, 74C1600966, 74E1901667, 74G1700718, 74J1501755, 74L1600387, 74A1602904, 74C1600972, 74F1502019, 74G1900066, 74J1601180, 74L1600389, 74A1603168, 74C1600976, 74F1600350, 74G1900340, 74J1603181, 74L1602761, 74A1603170, 74C1600977, 74F1602476, 74G1902629, 74J1800844, 74L1700357, 74A1701154, 74C1702793, 74F1602477, 74G1903756, 74K1500475, 74L1800444, 74A1802567, 74C1702794, 74F1702731, 74H1502508, 74K1500476, 74L1803409, 74A1903113, 74C1800357, 74F1800411, 74H1502510, 74K1501684, 74L1901787, 74A1903146, 74D1600123, 74F1802291, 74H1601384, 74K1501685, 74M1601318, 74B1501366, 74D1601266, 74F1802292, 74H1602748, 74K1900124, 74M1602080, 74B1501710, 74D1601524, 74G1500954, 74H1700589, 74K1900125, 74M1800915, 74B1600576, 74D1602673, 74G1500955, 74H1700590, 74K1900133, 74M1800916, 74B1600580, 74D1802317, 74G1503008, 74H1701427, 74K1901814, 74M1801620, 74B1601613, 74E1600837, 74G1503009, 74H1701863, 74L1501239, 74M1900014, 74B1601616, 74E1700596, 74G1602598, 74H1800764, 74L1501548 b) Teleflex Medical Disposable Aortic Punch, 3.6 mm, REF DP-36K Lot Numbers: 74A1601251, 74C1501114, 74E1600361, 74F1901768, 74H1602749, 74K1901790, 74A1602049, 74C1501504, 74E1600362, 74G1501254, 74H1802543, 74L1501933, 74A1602205, 74C1600454, 74E1700383, 74G1501584, 74H1802910, 74L1501934, 74A1603169, 74C1600978, 74E1700598, 74G1502240, 74H1900354, 74L1502651, 74A1801612, 74C1702795, 74E1800887, 74G1502247, 74H1901509, 74L1502668, 74A1901239, 74C1702796, 74E1802644, 74G1601150, 74J1501761, 74L1602762, 74A1902997, 74C1800358, 74E1900552, 74G1601151, 74J1501762, 74L1702282, 74A1903148, 74D1503157, 74E1901665, 74G1700719, 74J1702333, 74L1702978, 74B1501361, 74D1600124, 74F1500725, 74G1702124, 74J1702528, 74L1800993, 74B1600581, 74D1600125, 74F1502017, 74G1702125, 74J1703089, 74L1803139, 74B1601617, 74D1802318, 74F1502713, 74G1802091, 74J1900939, 74L1803408, 74B1602365, 74D1900834, 74F1502714, 74G1902121, 74J1901700, 74M1601319, 74B1602372, 74D1901907, 74F1600351, 74H1500734, 74K1500480, 74M1702625, 74B1800721, 74E1500848, 74F1703304, 74H1500735, 74K1501130, 74M1801251, 74B1800722, 74E1501779, 74F1801505, 74H1502517, 74K1501131, 74M1801622, 74B1902990, 74E1502618, 74F1802293, 74H1600757, 74K1502964, 74M1900012, 74B1903028, 74E1503095, 74F1900940, 74H1601385, 74K1600559 c) Teleflex Medical Disposable Aortic Punch, 4.0 mm, REF DP-40K Lot Numbers: 74A1501146, 74A1602181, 74A1702660, 74A1901901, 74B1602046, 74C1503228, 74A1501148, 74A1602360, 74A1800595, 74B1501126, 74B1800506, 74C1503232, 74A1502433, 74A1602361, 74A1800596, 74B1501358, 74B1800723, 74C1600455, 74A1502434, 74A1603161, 74A1801613, 74B1502260, 74B1801756, 74C1600460, 74A1502851, 74A1603162, 74A1802148, 74B1502261, 74B1802580, 74C1600967, 74A1502852, 74A1603163, 74A1802150, 74B1503151, 74C1501122, 74C1600979, 74A1503453, 74A1700378, 74A1802568, 74B1503152, 74C1501123, 74C1600980, 74A1601248, 74A1700766, 74A1900243, 74B1600577, 74C1501505, 74C1702893, 74A1601249, 74A1700767, 74A1900244, 74B1600582, 74C1502259, 74C1702894, 74A1601250, 74A1702659, 74A1901240, 74B1601618, 74C1502260, 74C1800359, 74C1800360, 74E1503093, 74F1601983, 74G1900067, 74H1903474, 74K1602893, 74C1801150, 74E1503099, 74F1602478, 74G1902118, 74J1500711, 74K1602894, 74C1900330, 74E1600838, 74F1602479, 74G1902119, 74J1500712, 74K1700910, 74C1900332, 74E1600839, 74F1603239, 74G1902833, 74J1501214, 74K1701639, 74C1900811, 74E1601257, 74F1603240, 74G1903729, 74J1501215, 74K1702121, 74C1900812, 74E1602244, 74F1700828, 74H1500732, 74J1501766, 74K1702122, 74C1901597, 74E1602245, 74F1701130, 74H1501603, 74J1501767, 74K1702866, 74C1902227, 74E1602810, 74F1701131, 74H1502506, 74J1502404, 74K1802890, 74C1902228, 74E1602811, 74F1702095, 74H1502507, 74J1502405, 74K1900758, 74D1500077, 74E1700599, 74F1702096, 74H1502530, 74J1600424, 74K1900759, 74D1500078, 74E1700600, 74F1702733, 74H1600758, 74J1600425, 74K1901792, 74D1501647, 74E1701203, 74F1702734, 74H1600759, 74J1601181, 74K1902250, 74D1501648, 74E1701234, 74F1703305, 74H1601386, 74J1601737, 74L1500801, 74D1503172, 74E1701236, 74F1800418, 74H1602468, 74J1602579, 74L1500810, 74D1600213, 74E1701755, 74F1801506, 74H1602469, 74J1602677, 74L1501230, 74D1600214, 74E1701758, 74F1802294, 74H1602750, 74J1602678, 74L1501231, 74D1600927, 74E1703220, 74F1802710, 74H1602751, 74J1700737, 74L1501983, 74D1601538, 74E1703236, 74F1802711, 74H1700591, 74J1700738, 74L1502663, 74D1602013, 74E1801602, 74F1900935, 74H1700592, 74J1701829, 74L1600400, 74D1602014, 74E1801603, 74F1900936, 74H1701429, 74J1702529, 74L1600440, 74D1602676, 74E1802105, 74F1900937, 74H1701431, 74J1702530, 74L1601327, 74D1700564, 74E1802106, 74F1901099, 74H1701839, 74J1703090, 74L1601328, 74D1700954, 74E1802645, 74F1901117, 74H1701869, 74J1703091, 74L1602113, 74D1700955, 74E1802984, 74F1901761, 74H1702709, 74J1800845, 74L1602763, 74D1701179, 74E1900554, 74G1500951, 74H1702710, 74J1801321, 74L1602764, 74D1702440, 74E1900593, 74G1501744, 74H1703164, 74J1801322, 74L1700358, 74D1801512, 74E1901447, 74G1502237, 74H1703165, 74J1802104, 74L1700359, 74D1802103, 74E1901448, 74G1503006, 74H1800761, 74J1802105, 74L1701122, 74D1802104, 74E1901663, 74G1600720, 74H1800763, 74J1802736, 74L1701124, 74D1802319, 74E1901664, 74G1601769, 74H1800838, 74J1900237, 74L1701786, 74D1802693, 74E1902715, 74G1602120, 74H1801707, 74J1900956, 74L1702283, 74D1802694, 74E1903772, 74G1602121, 74H1802544, 74J1901697, 74L1702979, 74D1900484, 74F1500753, 74G1602600, 74H1802911, 74J1901698, 74L1800558, 74D1900485, 74F1500754, 74G1700638, 74H1802912, 74J1903043, 74L1800559, 74D1900657, 74F1501151, 74G1700639, 74H1900352, 74K1500471, 74L1800994, 74D1900659, 74F1501152, 74G1701299, 74H1900353, 74K1500472, 74L1800995, 74D1901505, 74F1502021, 74G1701314, 74H1901108, 74K1501121, 74L1801431, 74D1902167, 74F1502022, 74G1702119, 74H1901109, 74K1501122, 74L1803140, 74D1902810, 74F1502217, 74G1702120, 74H1901115, 74K1501680, 74L1900199, 74D1902811, 74F1502710, 74G1800767, 74H1901116, 74K1502261, 74L1900200, 74D1902812, 74F1502711, 74G1800768, 74H1901510, 74K1502262, 74L1900201, 74E1501782, 74F1600352, 74G1801515, 74H1902119, 74K1502270, 74L1900202, 74E1501783, 74F1601101, 74G1802092, 74H1902737, 74K1600560, 74L1900361, 74E1502616, 74F1601102, 74G1802093, 74H1902738, 74K1601326, 74L1900362, 74E1502617, 74F1601325, 74G1802678, 74H1903398, 74K1602034, 74L1900858, 74L1900859, 74M1500805, 74M1601314, 74M1701819, 74M1801624, 74M1900367, 74L1901403, 74M1600393, 74M1602082, 74M1701820, 74M1900010, 74M1901094, 74L1901404, 74M1600394, 74M1701016, 74M1801252, 74M1900017, 74M1901095, 74L1901885, 74M1601313, 74M1701017, 74M1801253, 74M1900366 d) Teleflex Medical Disposable Aortic Punch, 4.4 mm, REF DP-44K Lot Numbers: 74A1501153, 74D1600217, 74E1900553, 74H1502520, 74J1700739, 74L1700360, 74A1502848, 74D1601525, 74E1903148, 74H1502909, 74J1701830, 74L1701125, 74A1602180, 74D1602016, 74E1903763, 74H1600761, 74J1701831, 74L1701787, 74A1800598, 74D1602268, 74F1600354, 74H1600762, 74J1702532, 74L1701788, 74A1801615, 74D1602679, 74F1600355, 74H1601224, 74J1703093, 74L1702285, 74A1801616, 74D1700951, 74F1601104, 74H1601387, 74J1800846, 74L1702981, 74A1802152, 74D1701786, 74F1601140, 74H1602470, 74J1801323, 74L1702982, 74A1802569, 74D1702441, 74F1601984, 74H1602471, 74J1802106, 74L1800560, 74A1900362, 74D1802105, 74F1601985, 74H1700594, 74J1900625, 74L1800561, 74A1901242, 74D1802106, 74F1603241, 74H1700595, 74J1901696, 74L1800997, 74A1901899, 74D1900483, 74F1603242, 74H1701435, 74J1903042, 74L1800998, 74A1902221, 74D1900658, 74F1702097, 74H1701864, 74K1500483, 74L1801771, 74A1902222, 74D1901506, 74F1702735, 74H1701865, 74K1501132, 74L1803136, 74A1902354, 74D1902168, 74F1800868, 74H1702712, 74K1501688, 74L1803261, 74B1501363, 74E1500841, 74F1801508, 74H1702713, 74K1600561, 74L1901191, 74B1502275, 74E1500842, 74F1802712, 74H1703166, 74K1601328, 74L1901200, 74B1601620, 74E1501992, 74F1900938, 74H1703282, 74K1601329, 74L1901201, 74B1602048, 74E1503098, 74G1502238, 74H1800765, 74K1700912, 74L1901407, 74B1602049, 74E1600364, 74G1503014, 74H1800840, 74K1700913, 74M1600396, 74B1800508, 74E1601723, 74G1600917, 74H1800841, 74K1701641, 74M1601316, 74B1800725, 74E1601724, 74G1601771, 74H1801709, 74K1701642, 74M1601317, 74B1800726, 74E1602248, 74G1601772, 74H1801710, 74K1702868, 74M1602089, 74B1801757, 74E1602812, 74G1602122, 74H1802546, 74K1702869, 74M1602090, 74B1802581, 74E1700602, 74G1602123, 74H1802914, 74K1900131, 74M1702628, 74B1802582, 74E1701406, 74G1602673, 74H1900355, 74K1901789, 74M1702629, 74C1501117, 74E1702791, 74G1602718, 74H1901113, 74K1901813, 74M1900011, 74C1501506, 74E1702792, 74G1700640, 74H1901511, 74L1501242, 74M1900372, 74C1600973, 74E1702796, 74G1701317, 74H1902120, 74L1502469, 74M1900689, 74C1600975, 74E1702797, 74G1701318, 74H1903403, 74L1600402, 74M1901097, 74C1702792, 74E1800889, 74G1801516, 74J1600426, 74L1600403, 74C1902226, 74E1801605, 74G1802681, 74J1600427, 74L1601647, 74D1500076, 74E1801606, 74G1900338, 74J1601203, 74L1601648, 74D1501516, 74E1802108, 74G1902123, 74J1602434, 74L1602115, 74D1501645, 74E1802109, 74G1902633, 74J1603182, 74L1602766, 74D1600216, 74E1802987, 74G1903757, 74J1603183, 74L1602767 e) Teleflex Medical Disposable Aortic Punch, 4.8 mm, REF DP-48K Lot Numbers: 74A1502850, 74A1801617, 74B1502262, 74B1802583, 74C1801152, 74D1600931, 74A1602182, 74A1802153, 74B1503158, 74B1901661, 74C1900329, 74D1601537, 74A1602901, 74A1901238, 74B1601609, 74C1501119, 74C1900618, 74D1602017, 74A1603164, 74A1901900, 74B1800505, 74C1600462, 74D1600226, 74D1602018, 74A1700763, 74A1902355, 74B1800719, 74C1600974, 74D1600227, 74D1700939, 74A1800600, 74B1501128, 74B1800727, 74C1600982, 74D1600930, 74D1700943, 74D1702442, 74F1600357, 74G1601774, 74H1701867, 74J1703095, 74K1900760, 74D1702443, 74F1600358, 74G1602124, 74H1701868, 74J1800847, 74K1901336, 74D1802107, 74F1601105, 74G1602719, 74H1702714, 74J1801324, 74L1500803, 74D1802321, 74F1601137, 74G1602720, 74H1800767, 74J1802108, 74L1600443, 74D1901508, 74F1601986, 74G1701319, 74H1800843, 74J1901706, 74L1602116, 74D1902169, 74F1602009, 74G1701320, 74H1800844, 74J1903044, 74L1701123, 74E1600842, 74F1603243, 74G1800770, 74H1802548, 74K1501123, 74L1701789, 74E1602249, 74F1702099, 74G1801517, 74H1802549, 74K1501124, 74L1702286, 74E1602813, 74F1702736, 74G1900337, 74H1802915, 74K1600562, 74L1800443, 74E1701837, 74F1702737, 74G1900339, 74H1900356, 74K1600563, 74L1800999, 74E1701838, 74F1703306, 74G1902120, 74H1901512, 74K1602037, 74L1803265, 74E1801607, 74F1800866, 74G1903728, 74J1501216, 74K1602038, 74M1600397, 74E1801608, 74F1801510, 74G1903758, 74J1501759, 74K1700915, 74M1602092, 74E1802646, 74F1802296, 74H1601389, 74J1600428, 74K1701643, 74M1701020, 74E1802647, 74F1900939, 74H1601390, 74J1601183, 74K1701644, 74M1702630, 74E1902716, 74F1901122, 74H1602472, 74J1601783, 74K1702870, 74M1702631, 74E1902717, 74F1902895, 74H1602752, 74J1602085, 74K1702871, 74M1800913, 74F1502712, 74G1501749, 74H1602753, 74J1700740, 74K1900128, 74M1900368, 74F1503522, 74G1601773, 74H1700596, 74J1701832, 74K1900129, 74M1901096 f) Teleflex Medical Disposable Aortic Punch, 5.2 mm, REF DP-52K Lot Numbers: 74A1601258, 74D1700800, 74F1602482, 74H1600764, 74K1602778, 74M1800914, 74A1700762, 74D1700820, 74F1701133, 74H1701443, 74K1700916, 74A1800602, 74D1701167, 74F1701134, 74H1702715, 74K1702872, 74A1903114, 74D1802322, 74F1800869, 74H1800846, 74K1900132, 74B1501364, 74D1802323, 74F1800870, 74H1801712, 74K1900761, 74B1503155, 74E1600843, 74F1801512, 74H1801713, 74K1901795, 74B1600584, 74E1602250, 74F1901098, 74H1802550, 74K1902045, 74B1602050, 74E1602814, 74G1500952, 74J1601733, 74K1902545, 74B1800510, 74E1700899, 74G1700720, 74J1602581, 74L1501241, 74B1800729, 74E1701840, 74G1900341, 74J1701833, 74L1602118, 74B1802584, 74E1701841, 74G1902122, 74J1802110, 74L1700361, 74B1900830, 74E1800897, 74G1902834, 74J1900239, 74L1800555, 74C1501507, 74E1900596, 74G1903730, 74J1901704, 74L1803267, 74C1902229, 74F1500755, 74G1903755, 74K1501689, 74M1600398, 74D1602269, 74F1601106, 74H1600763, 74K1600564, 74M1601320 g) Teleflex Medical Disposable Aortic Punch, 5.6 mm, REF DP-56K Lot Numbers: 74A1501142, 74B1600585, 74D1501515, 74F1500724, 74H1702716, 74K1902252, 74A1601256, 74B1601614, 74D1502568, 74F1502020, 74J1702533, 74L1501976, 74A1602204, 74B1601622, 74E1500845, 74F1702103, 74K1500481, 74L1502672, 74A1603172, 74B1602367, 74E1502580, 74F1800871, 74K1501683, 74M1900365, 74A1800603, 74B1800720, 74E1602815, 74F1801514, 74K1502970, 74M1900840, 74B1500704, 74C1501508, 74E1701843, 74F1801515, 74K1602779, 74M1901098, 74B1502274, 74C1600968, 74E1701844, 74F1802297, 74K1900126, 74M1901275, 74B1600578, 74D1500075, 74E1800898, 74G1902124, 74K1900127 h) Teleflex Medical Disposable Aortic Punch, 6.0 mm, REF DP-60K Lot Numbers: 74A1500172, 74E1502579, 74M1602094, 74E1800901, 74G1902125, 74D1501639, 74A1602907, 74H1700597, 74E1800902, 74K1901815, 74E1500846, 74E1602816, 74H1702717, 74G1900342 i) Teleflex Medical Disposable Aortic Punch, 2.8 mm, REF MDP-28K Lot Numbers: 74A1502835, 74A1902357, 74E1701845, 74F1902101, 74H1801714, 74A1601252, 74B1501360, 74E1901451, 74F1902891, 74H1802551, 74K1901816, 74A1602906, 74B1601615, 74F1500722, 74F1902892, 74J1702534, 74L1702287, 74A1800642, 74B1602374, 74F1501155, 74H1500733, 74J1901705, 74A1802572, 74B1801755, 74F1800872, 74H1702718, 74K1800082, 74A1901243, 74D1700801, 74F1802298, 74H1702719, 74K1900135 j) Teleflex Medical Disposable Aortic Punch, 3.6 mm, REF MDP-36K Lot Numbers: 74A1602184, 74B1602375, 74F1500984, 74H1601392, 74J1802111, 74L1702288, 74A1602185, 74C1702803, 74F1703309, 74H1701444, 74K1500473, 74L1702289, 74A1802573, 74C1702804, 74F1800873, 74H1702720, 74K1602780, 74L1901405, 74A1901218, 74C1802507, 74F1901968, 74H1801715, 74K1701646, 74L1901411, 74A1902223, 74C1802508, 74F1902108, 74H1802552, 74K1900134, 74M1901099, 74B1501261, 74E1600363, 74G1500956, 74H1802553, 74L1500804, 74B1600586, 74E1701846, 74G1502248, 74H1902743, 74L1500805, 74B1601623, 74E1701847, 74H1502513, 74J1500701, 74L1501981, 74B1602368, 74E1902721, 74H1502514, 74J1702535, 74L1501982 k) Teleflex Medical Disposable Aortic Punch, 4.0 mm, REF MDP-40K Lot Numbers: 74A1503439, 74C1802506, 74F1502715, 74G1602722, 74J1502407, 74K1801695, 74A1601257, 74C1900617, 74F1503526, 74G1800771, 74J1601185, 74L1500807, 74A1602908, 74D1600957, 74F1503527, 74G1801518, 74J1601186, 74L1500808, 74A1603166, 74D1600958, 74F1600359, 74G1802094, 74J1700494, 74L1501935, 74A1700734, 74D1601536, 74F1601332, 74G1902832, 74J1700742, 74L1501936, 74A1701848, 74D1602680, 74F1601333, 74H1500736, 74J1802112, 74L1602768, 74A1802574, 74D1700567, 74F1603244, 74H1502518, 74J1901699, 74L1602769, 74B1501131, 74D1700568, 74F1702104, 74H1502519, 74K1500478, 74L1701126, 74B1501365, 74D1800226, 74F1702105, 74H1602475, 74K1500479, 74L1702983, 74B1503154, 74D1800227, 74F1702738, 74H1602476, 74K1502266, 74L1900759, 74B1600587, 74E1502619, 74F1702739, 74H1701446, 74K1502268, 74L1900860, 74B1601624, 74E1503096, 74F1703310, 74H1702721, 74K1600565, 74M1602095, 74B1602369, 74E1601726, 74F1902081, 74H1902739, 74K1601332, 74M1701824, 74B1802585, 74E1602817, 74F1902177, 74H1902740, 74K1602781, 74M1701825, 74C1600456, 74E1602818, 74F1902178, 74H1902741, 74K1602782, 74M1900369, 74C1600984, 74F1500759, 74G1501993, 74H1903402, 74K1701647, 74M1901093, 74C1600985, 74F1501153, 74G1501994, 74J1501756, 74K1702867, 74C1802505, 74F1502018, 74G1602721, 74J1502406, 74K1800961 l) Teleflex Medical Disposable Aortic Punch, 4.4 mm, REF MDP-44K Lot Numbers: 74A1502836, 74B1902383, 74D1801513, 74F1802299, 74H1702722, 74K1702124, 74A1601255, 74C1503233, 74D1801514, 74F1901118, 74H1801716, 74K1800962, 74A1602179, 74C1702806, 74D1900660, 74G1500953, 74H1900358, 74K1801699, 74A1700760, 74C1801154, 74E1500844, 74G1601152, 74H1901513, 74L1501916, 74A1700761, 74C1900328, 74E1601486, 74G1602723, 74H1902742, 74L1502660, 74A1800643, 74C1901596, 74E1602252, 74G1700721, 74J1603175, 74L1601649, 74A1800644, 74D1601526, 74E1602819, 74G1802095, 74J1603176, 74L1700363, 74A1801620, 74D1601535, 74E1701849, 74H1502515, 74J1700743, 74L1700364, 74A1802575, 74D1602681, 74E1900594, 74H1601394, 74J1703098, 74L1702290, 74B1501359, 74D1700916, 74F1600360, 74H1601395, 74J1800849, 74L1702984, 74B1600575, 74D1800228, 74F1601138, 74H1701448, 74J1901702, 74L1801776, 74B1600588, 74D1800229, 74F1703312, 74H1701449, 74K1602783, 74L1900363, 74L1900760, 74M1602086, 74M1701826, 74L1901239, 74M1701022, 74M1900013 m) Teleflex Medical Disposable Aortic Punch, 4.8 mm, REF MDP-48K Lot Numbers: 74A1602178, 74C1902230, 74F1600361, 74H1502516, 74J1800850, 74K1801700, 74A1801621, 74D1503161, 74F1600362, 74H1601396, 74J1800851, 74K1801701, 74A1802576, 74D1602682, 74F1601982, 74H1602477, 74J1802113, 74L1501243, 74A1802577, 74D1700565, 74F1602484, 74H1603433, 74J1802740, 74L1602770, 74A1900255, 74D1700566, 74F1700830, 74H1701450, 74J1900241, 74L1700365, 74A1902358, 74D1800230, 74F1800874, 74H1701840, 74J1901703, 74L1701127, 74B1600589, 74D1800231, 74F1802300, 74H1802554, 74K1600566, 74L1803269, 74B1800512, 74E1501776, 74G1600722, 74H1901514, 74K1600567, 74L1901406, 74B1800730, 74E1601487, 74G1602125, 74H1903400, 74K1601333, 74M1601321, 74B1802586, 74E1601494, 74G1802096, 74J1501758, 74K1601334, 74M1602097, 74C1501509, 74E1703226, 74G1802684, 74J1600431, 74K1602784, 74M1701023, 74C1801155, 74E1801610, 74G1902626, 74J1601187, 74K1700917, 74M1701827, 74C1802503, 74E1802702, 74G1902835, 74J1601188, 74K1702873, 74M1701828, 74C1802504, 74E1901452, 74G1903731, 74J1702563, 74K1800963 n) Teleflex Medical Disposable Aortic Punch, 5.2 mm, REF MDP-52K Lot Numbers: 74A1603171, 74C1502258, 74D1902815, 74F1902890, 74H1701451, 74L1702291, 74A1603177, 74C1600457, 74F1500987, 74F1902893, 74H1701452, 74M1600399, 74A1801622, 74C1600464, 74F1600363, 74G1501260, 74H1801717, 74M1900015, 74A1900570, 74D1602270, 74F1702740, 74G1503013, 74J1502610, 74M1900690, 74A1903115, 74D1700574, 74F1702741, 74G1801519, 74K1502265, 74M1901101, 74B1501133, 74D1700575, 74F1800875, 74H1502512, 74K1602785, 74C1501510, 74D1800232, 74F1902113, 74H1601397, 74L1500806 o) Teleflex Medical Disposable Aortic Punch, 5.6 mm, REF MDP-56K Lot Numbers: 74A1502837, 74A1601260, 74A1602183, 74B1600579, 74C1600458, 74D1901016 p) Teleflex Medical Disposable Aortic Punch, 6.0 mm, REF MDP-60K Lot Numbers: 74A1500226, 74B1503153, 74C1900613, 74F1602485, 74H1500728, 74J1602582, 74A1601259, 74B1602370, 74D1500074, 74F1702742, 74H1502910, 74J1901701, 74A1700732, 74C1502256, 74D1700569, 74F1800876, 74H1601398, 74K1800083, 74A1801623, 74C1600459, 74D1801515, 74G1501745, 74H1702723, 74K1901793, 74A1802579, 74C1600970, 74E1700603, 74G1801520, 74H1702724, 74L1601650, 74A1901241, 74C1800374, 74F1500723, 74G1902631, 74H1801718, 74L1700366, 74B1501262, 74C1802502, 74F1502701, 74G1902818, 74H1802917

Quantity recalled587066 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1270-2020
FDA event ID: 84722
Recalling firm: Teleflex Medical, Morrisville, NC
Classification: Class II
Status: Terminated
Recall initiated: 13 Jan 2020
FDA classified: 19 Feb 2020
Reported: 26 Feb 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Heart & Vascular Devices

Timeline

13 Jan 2020	Recall initiated by company
19 Feb 2020	Classified by FDA	+37 days
26 Feb 2020	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

There is a potential for the device packaging to become compromised; thus, the sterility of the device cannot be guaranteed.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Teleflex Medical Disposable Aortic Punch, in the following sizes: a) 2.8 mm, REF DP-28K b) 3.6 mm, REF DP-36K c) 4.0 mm, REF DP-40K d) 4.4 mm, REF DP-44K e) 4.8 mm, REF DP-48K f) 5.2 mm, REF DP-52K g) 5.6 mm, REF DP-56K h) 6.0 mm, REF DP-60K i) 2.8 mm, REF MDP-28K j) 3.6 mm, REF MDP-36K k) 4.0 mm, REF MDP-40K l) 4.4 mm, REF MDP-44K m) 4.8 mm, REF MDP-48K n) 5.2 mm, REF MDP-52K o) 5.6 mm, REF MDP-56K p) 6.0 mm, REF MDP-60K

Where it was distributed

Worldwide

Questions about this recall

Why was it recalled?

There is a potential for the device packaging to become compromised; thus, the sterility of the device cannot be guaranteed.

Which lots are affected?

a) Teleflex Medical Disposable Aortic Punch, 2.8 mm, REF DP-28K Lot Numbers: 74A1501140, 74B1602364, 74E1700597, 74G1602599, 74H1900357, 74L1501549, 74A1601253, 74B1900832, 74E1800886, 74G1700636, 74J1501218, 74L1501977, 74A1601254, 74C1501113, 74E1802643, 74G1700637, 74J1501754, 74L1501978, 74A1602903, 74C1600966, 74E1901667, 74G1700718, 74J1501755, 74L1600387, 74A1602904, 74C1600972, 74F1502019, 74G1900066, 74J1601180, 74L1600389, 74A1603168, 74C1600976, 74F1600350, 74G1900340, 74J1603181, 74L1602761, 74A1603170, 74C1600977, 74F1602476, 74G1902629, 74J1800844, 74L1700357, 74A1701154, 74C1702793, 74F1602477, 74G1903756, 74K1500475, 74L1800444, 74A1802567, 74C1702794, 74F1702731, 74H1502508, 74K1500476, 74L1803409, 74A1903113, 74C1800357, 74F1800411, 74H1502510, 74K1501684, 74L1901787, 74A1903146, 74D1600123, 74F1802291, 74H1601384, 74K1501685, 74M1601318, 74B1501366, 74D1601266, 74F1802292, 74H1602748, 74K1900124, 74M1602080, 74B1501710, 74D1601524, 74G1500954, 74H1700589, 74K1900125, 74M1800915, 74B1600576, 74D1602673, 74G1500955, 74H1700590, 74K1900133, 74M1800916, 74B1600580, 74D1802317, 74G1503008, 74H1701427, 74K1901814, 74M1801620, 74B1601613, 74E1600837, 74G1503009, 74H1701863, 74L1501239, 74M1900014, 74B1601616, 74E1700596, 74G1602598, 74H1800764, 74L1501548 b) Teleflex Medical Disposable Aortic Punch, 3.6 mm, REF DP-36K Lot Numbers: 74A1601251, 74C1501114, 74E1600361, 74F1901768, 74H1602749, 74K1901790, 74A1602049, 74C1501504, 74E1600362, 74G1501254, 74H1802543, 74L1501933, 74A1602205, 74C1600454, 74E1700383, 74G1501584, 74H1802910, 74L1501934, 74A1603169, 74C1600978, 74E1700598, 74G1502240, 74H1900354, 74L1502651, 74A1801612, 74C1702795, 74E1800887, 74G1502247, 74H1901509, 74L1502668, 74A1901239, 74C1702796, 74E1802644, 74G1601150, 74J1501761, 74L1602762, 74A1902997, 74C1800358, 74E1900552, 74G1601151, 74J1501762, 74L1702282, 74A1903148, 74D1503157, 74E1901665, 74G1700719, 74J1702333, 74L1702978, 74B1501361, 74D1600124, 74F1500725, 74G1702124, 74J1702528, 74L1800993, 74B1600581, 74D1600125, 74F1502017, 74G1702125, 74J1703089, 74L1803139, 74B1601617, 74D1802318, 74F1502713, 74G1802091, 74J1900939, 74L1803408, 74B1602365, 74D1900834, 74F1502714, 74G1902121, 74J1901700, 74M1601319, 74B1602372, 74D1901907, 74F1600351, 74H1500734, 74K1500480, 74M1702625, 74B1800721, 74E1500848, 74F1703304, 74H1500735, 74K1501130, 74M1801251, 74B1800722, 74E1501779, 74F1801505, 74H1502517, 74K1501131, 74M1801622, 74B1902990, 74E1502618, 74F1802293, 74H1600757, 74K1502964, 74M1900012, 74B1903028, 74E1503095, 74F1900940, 74H1601385, 74K1600559 c) Teleflex Medical Disposable Aortic Punch, 4.0 mm, REF DP-40K Lot Numbers: 74A1501146, 74A1602181, 74A1702660, 74A1901901, 74B1602046, 74C1503228, 74A1501148, 74A1602360, 74A1800595, 74B1501126, 74B1800506, 74C1503232, 74A1502433, 74A1602361, 74A1800596, 74B1501358, 74B1800723, 74C1600455, 74A1502434, 74A1603161, 74A1801613, 74B1502260, 74B1801756, 74C1600460, 74A1502851, 74A1603162, 74A1802148, 74B1502261, 74B1802580, 74C1600967, 74A1502852, 74A1603163, 74A1802150, 74B1503151, 74C1501122, 74C1600979, 74A1503453, 74A1700378, 74A1802568, 74B1503152, 74C1501123, 74C1600980, 74A1601248, 74A1700766, 74A1900243, 74B1600577, 74C1501505, 74C1702893, 74A1601249, 74A1700767, 74A1900244, 74B1600582, 74C1502259, 74C1702894, 74A1601250, 74A1702659, 74A1901240, 74B1601618, 74C1502260, 74C1800359, 74C1800360, 74E1503093, 74F1601983, 74G1900067, 74H1903474, 74K1602893, 74C1801150, 74E1503099, 74F1602478, 74G1902118, 74J1500711, 74K1602894, 74C1900330, 74E1600838, 74F1602479, 74G1902119, 74J1500712, 74K1700910, 74C1900332, 74E1600839, 74F1603239, 74G1902833, 74J1501214, 74K1701639, 74C1900811, 74E1601257, 74F1603240, 74G1903729, 74J1501215, 74K1702121, 74C1900812, 74E1602244, 74F1700828, 74H1500732, 74J1501766, 74K1702122, 74C1901597, 74E1602245, 74F1701130, 74H1501603, 74J1501767, 74K1702866, 74C1902227, 74E1602810, 74F1701131, 74H1502506, 74J1502404, 74K1802890, 74C1902228, 74E1602811, 74F1702095, 74H1502507, 74J1502405, 74K1900758, 74D1500077, 74E1700599, 74F1702096, 74H1502530, 74J1600424, 74K1900759, 74D1500078, 74E1700600, 74F1702733, 74H1600758, 74J1600425, 74K1901792, 74D1501647, 74E1701203, 74F1702734, 74H1600759, 74J1601181, 74K1902250, 74D1501648, 74E1701234, 74F1703305, 74H1601386, 74J1601737, 74L1500801, 74D1503172, 74E1701236, 74F1800418, 74H1602468, 74J1602579, 74L1500810, 74D1600213, 74E1701755, 74F1801506, 74H1602469, 74J1602677, 74L1501230, 74D1600214, 74E1701758, 74F1802294, 74H1602750, 74J1602678, 74L1501231, 74D1600927, 74E1703220, 74F1802710, 74H1602751, 74J1700737, 74L1501983, 74D1601538, 74E1703236, 74F1802711, 74H1700591, 74J1700738, 74L1502663, 74D1602013, 74E1801602, 74F1900935, 74H1700592, 74J1701829, 74L1600400, 74D1602014, 74E1801603, 74F1900936, 74H1701429, 74J1702529, 74L1600440, 74D1602676, 74E1802105, 74F1900937, 74H1701431, 74J1702530, 74L1601327, 74D1700564, 74E1802106, 74F1901099, 74H1701839, 74J1703090, 74L1601328, 74D1700954, 74E1802645, 74F1901117, 74H1701869, 74J1703091, 74L1602113, 74D1700955, 74E1802984, 74F1901761, 74H1702709, 74J1800845, 74L1602763, 74D1701179, 74E1900554, 74G1500951, 74H1702710, 74J1801321, 74L1602764, 74D1702440, 74E1900593, 74G1501744, 74H1703164, 74J1801322, 74L1700358, 74D1801512, 74E1901447, 74G1502237, 74H1703165, 74J1802104, 74L1700359, 74D1802103, 74E1901448, 74G1503006, 74H1800761, 74J1802105, 74L1701122, 74D1802104, 74E1901663, 74G1600720, 74H1800763, 74J1802736, 74L1701124, 74D1802319, 74E1901664, 74G1601769, 74H1800838, 74J1900237, 74L1701786, 74D1802693, 74E1902715, 74G1602120, 74H1801707, 74J1900956, 74L1702283, 74D1802694, 74E1903772, 74G1602121, 74H1802544, 74J1901697, 74L1702979, 74D1900484, 74F1500753, 74G1602600, 74H1802911, 74J1901698, 74L1800558, 74D1900485, 74F1500754, 74G1700638, 74H1802912, 74J1903043, 74L1800559, 74D1900657, 74F1501151, 74G1700639, 74H1900352, 74K1500471, 74L1800994, 74D1900659, 74F1501152, 74G1701299, 74H1900353, 74K1500472, 74L1800995, 74D1901505, 74F1502021, 74G1701314, 74H1901108, 74K1501121, 74L1801431, 74D1902167, 74F1502022, 74G1702119, 74H1901109, 74K1501122, 74L1803140, 74D1902810, 74F1502217, 74G1702120, 74H1901115, 74K1501680, 74L1900199, 74D1902811, 74F1502710, 74G1800767, 74H1901116, 74K1502261, 74L1900200, 74D1902812, 74F1502711, 74G1800768, 74H1901510, 74K1502262, 74L1900201, 74E1501782, 74F1600352, 74G1801515, 74H1902119, 74K1502270, 74L1900202, 74E1501783, 74F1601101, 74G1802092, 74H1902737, 74K1600560, 74L1900361, 74E1502616, 74F1601102, 74G1802093, 74H1902738, 74K1601326, 74L1900362, 74E1502617, 74F1601325, 74G1802678, 74H1903398, 74K1602034, 74L1900858, 74L1900859, 74M1500805, 74M1601314, 74M1701819, 74M1801624, 74M1900367, 74L1901403, 74M1600393, 74M1602082, 74M1701820, 74M1900010, 74M1901094, 74L1901404, 74M1600394, 74M1701016, 74M1801252, 74M1900017, 74M1901095, 74L1901885, 74M1601313, 74M1701017, 74M1801253, 74M1900366 d) Teleflex Medical Disposable Aortic Punch, 4.4 mm, REF DP-44K Lot Numbers: 74A1501153, 74D1600217, 74E1900553, 74H1502520, 74J1700739, 74L1700360, 74A1502848, 74D1601525, 74E1903148, 74H1502909, 74J1701830, 74L1701125, 74A1602180, 74D1602016, 74E1903763, 74H1600761, 74J1701831, 74L1701787, 74A1800598, 74D1602268, 74F1600354, 74H1600762, 74J1702532, 74L1701788, 74A1801615, 74D1602679, 74F1600355, 74H1601224, 74J1703093, 74L1702285, 74A1801616, 74D1700951, 74F1601104, 74H1601387, 74J1800846, 74L1702981, 74A1802152, 74D1701786, 74F1601140, 74H1602470, 74J1801323, 74L1702982, 74A1802569, 74D1702441, 74F1601984, 74H1602471, 74J1802106, 74L1800560, 74A1900362, 74D1802105, 74F1601985, 74H1700594, 74J1900625, 74L1800561, 74A1901242, 74D1802106, 74F1603241, 74H1700595, 74J1901696, 74L1800997, 74A1901899, 74D1900483, 74F1603242, 74H1701435, 74J1903042, 74L1800998, 74A1902221, 74D1900658, 74F1702097, 74H1701864, 74K1500483, 74L1801771, 74A1902222, 74D1901506, 74F1702735, 74H1701865, 74K1501132, 74L1803136, 74A1902354, 74D1902168, 74F1800868, 74H1702712, 74K1501688, 74L1803261, 74B1501363, 74E1500841, 74F1801508, 74H1702713, 74K1600561, 74L1901191, 74B1502275, 74E1500842, 74F1802712, 74H1703166, 74K1601328, 74L1901200, 74B1601620, 74E1501992, 74F1900938, 74H1703282, 74K1601329, 74L1901201, 74B1602048, 74E1503098, 74G1502238, 74H1800765, 74K1700912, 74L1901407, 74B1602049, 74E1600364, 74G1503014, 74H1800840, 74K1700913, 74M1600396, 74B1800508, 74E1601723, 74G1600917, 74H1800841, 74K1701641, 74M1601316, 74B1800725, 74E1601724, 74G1601771, 74H1801709, 74K1701642, 74M1601317, 74B1800726, 74E1602248, 74G1601772, 74H1801710, 74K1702868, 74M1602089, 74B1801757, 74E1602812, 74G1602122, 74H1802546, 74K1702869, 74M1602090, 74B1802581, 74E1700602, 74G1602123, 74H1802914, 74K1900131, 74M1702628, 74B1802582, 74E1701406, 74G1602673, 74H1900355, 74K1901789, 74M1702629, 74C1501117, 74E1702791, 74G1602718, 74H1901113, 74K1901813, 74M1900011, 74C1501506, 74E1702792, 74G1700640, 74H1901511, 74L1501242, 74M1900372, 74C1600973, 74E1702796, 74G1701317, 74H1902120, 74L1502469, 74M1900689, 74C1600975, 74E1702797, 74G1701318, 74H1903403, 74L1600402, 74M1901097, 74C1702792, 74E1800889, 74G1801516, 74J1600426, 74L1600403, 74C1902226, 74E1801605, 74G1802681, 74J1600427, 74L1601647, 74D1500076, 74E1801606, 74G1900338, 74J1601203, 74L1601648, 74D1501516, 74E1802108, 74G1902123, 74J1602434, 74L1602115, 74D1501645, 74E1802109, 74G1902633, 74J1603182, 74L1602766, 74D1600216, 74E1802987, 74G1903757, 74J1603183, 74L1602767 e) Teleflex Medical Disposable Aortic Punch, 4.8 mm, REF DP-48K Lot Numbers: 74A1502850, 74A1801617, 74B1502262, 74B1802583, 74C1801152, 74D1600931, 74A1602182, 74A1802153, 74B1503158, 74B1901661, 74C1900329, 74D1601537, 74A1602901, 74A1901238, 74B1601609, 74C1501119, 74C1900618, 74D1602017, 74A1603164, 74A1901900, 74B1800505, 74C1600462, 74D1600226, 74D1602018, 74A1700763, 74A1902355, 74B1800719, 74C1600974, 74D1600227, 74D1700939, 74A1800600, 74B1501128, 74B1800727, 74C1600982, 74D1600930, 74D1700943, 74D1702442, 74F1600357, 74G1601774, 74H1701867, 74J1703095, 74K1900760, 74D1702443, 74F1600358, 74G1602124, 74H1701868, 74J1800847, 74K1901336, 74D1802107, 74F1601105, 74G1602719, 74H1702714, 74J1801324, 74L1500803, 74D1802321, 74F1601137, 74G1602720, 74H1800767, 74J1802108, 74L1600443, 74D1901508, 74F1601986, 74G1701319, 74H1800843, 74J1901706, 74L1602116, 74D1902169, 74F1602009, 74G1701320, 74H1800844, 74J1903044, 74L1701123, 74E1600842, 74F1603243, 74G1800770, 74H1802548, 74K1501123, 74L1701789, 74E1602249, 74F1702099, 74G1801517, 74H1802549, 74K1501124, 74L1702286, 74E1602813, 74F1702736, 74G1900337, 74H1802915, 74K1600562, 74L1800443, 74E1701837, 74F1702737, 74G1900339, 74H1900356, 74K1600563, 74L1800999, 74E1701838, 74F1703306, 74G1902120, 74H1901512, 74K1602037, 74L1803265, 74E1801607, 74F1800866, 74G1903728, 74J1501216, 74K1602038, 74M1600397, 74E1801608, 74F1801510, 74G1903758, 74J1501759, 74K1700915, 74M1602092, 74E1802646, 74F1802296, 74H1601389, 74J1600428, 74K1701643, 74M1701020, 74E1802647, 74F1900939, 74H1601390, 74J1601183, 74K1701644, 74M1702630, 74E1902716, 74F1901122, 74H1602472, 74J1601783, 74K1702870, 74M1702631, 74E1902717, 74F1902895, 74H1602752, 74J1602085, 74K1702871, 74M1800913, 74F1502712, 74G1501749, 74H1602753, 74J1700740, 74K1900128, 74M1900368, 74F1503522, 74G1601773, 74H1700596, 74J1701832, 74K1900129, 74M1901096 f) Teleflex Medical Disposable Aortic Punch, 5.2 mm, REF DP-52K Lot Numbers: 74A1601258, 74D1700800, 74F1602482, 74H1600764, 74K1602778, 74M1800914, 74A1700762, 74D1700820, 74F1701133, 74H1701443, 74K1700916, 74A1800602, 74D1701167, 74F1701134, 74H1702715, 74K1702872, 74A1903114, 74D1802322, 74F1800869, 74H1800846, 74K1900132, 74B1501364, 74D1802323, 74F1800870, 74H1801712, 74K1900761, 74B1503155, 74E1600843, 74F1801512, 74H1801713, 74K1901795, 74B1600584, 74E1602250, 74F1901098, 74H1802550, 74K1902045, 74B1602050, 74E1602814, 74G1500952, 74J1601733, 74K1902545, 74B1800510, 74E1700899, 74G1700720, 74J1602581, 74L1501241, 74B1800729, 74E1701840, 74G1900341, 74J1701833, 74L1602118, 74B1802584, 74E1701841, 74G1902122, 74J1802110, 74L1700361, 74B1900830, 74E1800897, 74G1902834, 74J1900239, 74L1800555, 74C1501507, 74E1900596, 74G1903730, 74J1901704, 74L1803267, 74C1902229, 74F1500755, 74G1903755, 74K1501689, 74M1600398, 74D1602269, 74F1601106, 74H1600763, 74K1600564, 74M1601320 g) Teleflex Medical Disposable Aortic Punch, 5.6 mm, REF DP-56K Lot Numbers: 74A1501142, 74B1600585, 74D1501515, 74F1500724, 74H1702716, 74K1902252, 74A1601256, 74B1601614, 74D1502568, 74F1502020, 74J1702533, 74L1501976, 74A1602204, 74B1601622, 74E1500845, 74F1702103, 74K1500481, 74L1502672, 74A1603172, 74B1602367, 74E1502580, 74F1800871, 74K1501683, 74M1900365, 74A1800603, 74B1800720, 74E1602815, 74F1801514, 74K1502970, 74M1900840, 74B1500704, 74C1501508, 74E1701843, 74F1801515, 74K1602779, 74M1901098, 74B1502274, 74C1600968, 74E1701844, 74F1802297, 74K1900126, 74M1901275, 74B1600578, 74D1500075, 74E1800898, 74G1902124, 74K1900127 h) Teleflex Medical Disposable Aortic Punch, 6.0 mm, REF DP-60K Lot Numbers: 74A1500172, 74E1502579, 74M1602094, 74E1800901, 74G1902125, 74D1501639, 74A1602907, 74H1700597, 74E1800902, 74K1901815, 74E1500846, 74E1602816, 74H1702717, 74G1900342 i) Teleflex Medical Disposable Aortic Punch, 2.8 mm, REF MDP-28K Lot Numbers: 74A1502835, 74A1902357, 74E1701845, 74F1902101, 74H1801714, 74A1601252, 74B1501360, 74E1901451, 74F1902891, 74H1802551, 74K1901816, 74A1602906, 74B1601615, 74F1500722, 74F1902892, 74J1702534, 74L1702287, 74A1800642, 74B1602374, 74F1501155, 74H1500733, 74J1901705, 74A1802572, 74B1801755, 74F1800872, 74H1702718, 74K1800082, 74A1901243, 74D1700801, 74F1802298, 74H1702719, 74K1900135 j) Teleflex Medical Disposable Aortic Punch, 3.6 mm, REF MDP-36K Lot Numbers: 74A1602184, 74B1602375, 74F1500984, 74H1601392, 74J1802111, 74L1702288, 74A1602185, 74C1702803, 74F1703309, 74H1701444, 74K1500473, 74L1702289, 74A1802573, 74C1702804, 74F1800873, 74H1702720, 74K1602780, 74L1901405, 74A1901218, 74C1802507, 74F1901968, 74H1801715, 74K1701646, 74L1901411, 74A1902223, 74C1802508, 74F1902108, 74H1802552, 74K1900134, 74M1901099, 74B1501261, 74E1600363, 74G1500956, 74H1802553, 74L1500804, 74B1600586, 74E1701846, 74G1502248, 74H1902743, 74L1500805, 74B1601623, 74E1701847, 74H1502513, 74J1500701, 74L1501981, 74B1602368, 74E1902721, 74H1502514, 74J1702535, 74L1501982 k) Teleflex Medical Disposable Aortic Punch, 4.0 mm, REF MDP-40K Lot Numbers: 74A1503439, 74C1802506, 74F1502715, 74G1602722, 74J1502407, 74K1801695, 74A1601257, 74C1900617, 74F1503526, 74G1800771, 74J1601185, 74L1500807, 74A1602908, 74D1600957, 74F1503527, 74G1801518, 74J1601186, 74L1500808, 74A1603166, 74D1600958, 74F1600359, 74G1802094, 74J1700494, 74L1501935, 74A1700734, 74D1601536, 74F1601332, 74G1902832, 74J1700742, 74L1501936, 74A1701848, 74D1602680, 74F1601333, 74H1500736, 74J1802112, 74L1602768, 74A1802574, 74D1700567, 74F1603244, 74H1502518, 74J1901699, 74L1602769, 74B1501131, 74D1700568, 74F1702104, 74H1502519, 74K1500478, 74L1701126, 74B1501365, 74D1800226, 74F1702105, 74H1602475, 74K1500479, 74L1702983, 74B1503154, 74D1800227, 74F1702738, 74H1602476, 74K1502266, 74L1900759, 74B1600587, 74E1502619, 74F1702739, 74H1701446, 74K1502268, 74L1900860, 74B1601624, 74E1503096, 74F1703310, 74H1702721, 74K1600565, 74M1602095, 74B1602369, 74E1601726, 74F1902081, 74H1902739, 74K1601332, 74M1701824, 74B1802585, 74E1602817, 74F1902177, 74H1902740, 74K1602781, 74M1701825, 74C1600456, 74E1602818, 74F1902178, 74H1902741, 74K1602782, 74M1900369, 74C1600984, 74F1500759, 74G1501993, 74H1903402, 74K1701647, 74M1901093, 74C1600985, 74F1501153, 74G1501994, 74J1501756, 74K1702867, 74C1802505, 74F1502018, 74G1602721, 74J1502406, 74K1800961 l) Teleflex Medical Disposable Aortic Punch, 4.4 mm, REF MDP-44K Lot Numbers: 74A1502836, 74B1902383, 74D1801513, 74F1802299, 74H1702722, 74K1702124, 74A1601255, 74C1503233, 74D1801514, 74F1901118, 74H1801716, 74K1800962, 74A1602179, 74C1702806, 74D1900660, 74G1500953, 74H1900358, 74K1801699, 74A1700760, 74C1801154, 74E1500844, 74G1601152, 74H1901513, 74L1501916, 74A1700761, 74C1900328, 74E1601486, 74G1602723, 74H1902742, 74L1502660, 74A1800643, 74C1901596, 74E1602252, 74G1700721, 74J1603175, 74L1601649, 74A1800644, 74D1601526, 74E1602819, 74G1802095, 74J1603176, 74L1700363, 74A1801620, 74D1601535, 74E1701849, 74H1502515, 74J1700743, 74L1700364, 74A1802575, 74D1602681, 74E1900594, 74H1601394, 74J1703098, 74L1702290, 74B1501359, 74D1700916, 74F1600360, 74H1601395, 74J1800849, 74L1702984, 74B1600575, 74D1800228, 74F1601138, 74H1701448, 74J1901702, 74L1801776, 74B1600588, 74D1800229, 74F1703312, 74H1701449, 74K1602783, 74L1900363, 74L1900760, 74M1602086, 74M1701826, 74L1901239, 74M1701022, 74M1900013 m) Teleflex Medical Disposable Aortic Punch, 4.8 mm, REF MDP-48K Lot Numbers: 74A1602178, 74C1902230, 74F1600361, 74H1502516, 74J1800850, 74K1801700, 74A1801621, 74D1503161, 74F1600362, 74H1601396, 74J1800851, 74K1801701, 74A1802576, 74D1602682, 74F1601982, 74H1602477, 74J1802113, 74L1501243, 74A1802577, 74D1700565, 74F1602484, 74H1603433, 74J1802740, 74L1602770, 74A1900255, 74D1700566, 74F1700830, 74H1701450, 74J1900241, 74L1700365, 74A1902358, 74D1800230, 74F1800874, 74H1701840, 74J1901703, 74L1701127, 74B1600589, 74D1800231, 74F1802300, 74H1802554, 74K1600566, 74L1803269, 74B1800512, 74E1501776, 74G1600722, 74H1901514, 74K1600567, 74L1901406, 74B1800730, 74E1601487, 74G1602125, 74H1903400, 74K1601333, 74M1601321, 74B1802586, 74E1601494, 74G1802096, 74J1501758, 74K1601334, 74M1602097, 74C1501509, 74E1703226, 74G1802684, 74J1600431, 74K1602784, 74M1701023, 74C1801155, 74E1801610, 74G1902626, 74J1601187, 74K1700917, 74M1701827, 74C1802503, 74E1802702, 74G1902835, 74J1601188, 74K1702873, 74M1701828, 74C1802504, 74E1901452, 74G1903731, 74J1702563, 74K1800963 n) Teleflex Medical Disposable Aortic Punch, 5.2 mm, REF MDP-52K Lot Numbers: 74A1603171, 74C1502258, 74D1902815, 74F1902890, 74H1701451, 74L1702291, 74A1603177, 74C1600457, 74F1500987, 74F1902893, 74H1701452, 74M1600399, 74A1801622, 74C1600464, 74F1600363, 74G1501260, 74H1801717, 74M1900015, 74A1900570, 74D1602270, 74F1702740, 74G1503013, 74J1502610, 74M1900690, 74A1903115, 74D1700574, 74F1702741, 74G1801519, 74K1502265, 74M1901101, 74B1501133, 74D1700575, 74F1800875, 74H1502512, 74K1602785, 74C1501510, 74D1800232, 74F1902113, 74H1601397, 74L1500806 o) Teleflex Medical Disposable Aortic Punch, 5.6 mm, REF MDP-56K Lot Numbers: 74A1502837, 74A1601260, 74A1602183, 74B1600579, 74C1600458, 74D1901016 p) Teleflex Medical Disposable Aortic Punch, 6.0 mm, REF MDP-60K Lot Numbers: 74A1500226, 74B1503153, 74C1900613, 74F1602485, 74H1500728, 74J1602582, 74A1601259, 74B1602370, 74D1500074, 74F1702742, 74H1502910, 74J1901701, 74A1700732, 74C1502256, 74D1700569, 74F1800876, 74H1601398, 74K1800083, 74A1801623, 74C1600459, 74D1801515, 74G1501745, 74H1702723, 74K1901793, 74A1802579, 74C1600970, 74E1700603, 74G1801520, 74H1702724, 74L1601650, 74A1901241, 74C1800374, 74F1500723, 74G1902631, 74H1801718, 74L1700366, 74B1501262, 74C1802502, 74F1502701, 74G1902818, 74H1802917

Where was it sold?

Worldwide

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 84722

This product is part of a recall event; the main page for the event is Pilling Aortic Punch Standard Tip recalled by Teleflex Medical.

Reported	Class	Recall	Company	Reason	Where
26 Feb 2020	CLASS II	Pilling Aortic Punch Standard Tip recalled by Teleflex Medical	Teleflex Medical	Sterility	NC

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All 235

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1 Jun 2022Device	CLASS II	Teleflex Flex tube, Product #20011, sterile recalled by Teleflex Medical	Teleflex Medical	Other	Nationwide
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23 Feb 2022Device	CLASS I	Arrow-Trerotola Over-The-Wire PTD Kit recalled by Teleflex Medical	Teleflex Medical	Other	Nationwide
23 Feb 2022Device	CLASS I	Arrow-Trerotola Over-The-Wire PTD Kit recalled by Teleflex Medical	Teleflex Medical	Other	Nationwide
23 Feb 2022Device	CLASS I	Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device) recalled	Teleflex Medical	Other	Nationwide

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7 Oct 2026Device	CLASS II	Medical convenience kits containing BD CliniClean Pericare recalled	American Contract Systems	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Medical convenience kits containing BD CliniClean Pericare recalled	American Contract Systems	Device Malfunction	Nationwide