TELEFLEX MEDICAL INC: 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

Recall number

Z-1270-2020

Recalling firm

TELEFLEX MEDICAL INC

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

Status

Terminated

Initiated

2020-01-13

Posted

2020-01-27

Terminated

2021-11-24

Reason

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

Root 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

587066 units

Distribution

Worldwide

Lot, serial or model codes

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

510(k) numbers

not on file

PMA numbers

not on file

Product code

DWS

Firm FEI

3005747797

Firm city

Morrisville

Firm state

NC

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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