Class 2 Device Recall Disposable Aortic Punch

• Date Initiated by Firm: January 13, 2020
• Date Posted: January 27, 2020
• Recall Status: Terminated on November 24, 2021
• Recall Number: Z-1270-2020
• Recall Event ID: 84722
• Product Classification: Instruments, Surgical, Cardiovascular - Product Code DWS
• Product: 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
• Code Information: 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
• Recalling Firm/ Manufacturer: TELEFLEX MEDICAL INC; 3015 Carrington Mill Blvd; Morrisville NC 27560-5437
• Manufacturer Reason for Recall: There is a potential for the device packaging to become compromised; thus, the sterility of the device cannot be guaranteed.
• FDA Determined Cause: Under Investigation by firm
• Action: The firm initiated the recall by letter on 01/13/2020. The actions to be taking be the consignees are as follows: Check inventory. If affected stock is found, discontinue use immediately and quarantine. Complete the acknowledgement form as soon as possible indicating whether you do or do not have stock and fax it to 1-855-419-8507 or email to recalls@teleflex.com. A customer service representative will contact you with a Return Goods Authorization (RGA) number and provide instructions for the return of products. For additional questions, contact the local sales representative or Customer Service at 1-866-396-2111.
• Quantity in Commerce: 587066 units
• Distribution: Worldwide
• 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.