510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
Z-1270-2020Class II

Teleflex Medical Disposable Aortic Punch, in the following sizes: a) 2.8 mm, REF DP-28K b) 3.6 mm, REF DP-36K...

Teleflex Medical / initiated 2020-01-13 / Terminated / root cause: packaging
FDA source (opens on fda.gov)

TELEFLEX MEDICAL INC began a recall of 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)... on . FDA classified it as Class II and gives the reason as "There is a potential for the device packaging to become compromised; thus, the sterility of the device cannot be guaranteed". As of , the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number
Z-1270-2020
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Teleflex Medical
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
Product code
DWS Instruments, Surgical, Cardiovascular
Reason for recall
There is a potential for the device packaging to become compromised; thus, the sterility of the device cannot be guaranteed.
Root cause tag
packaging
FDA 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 [email protected]. 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
Product codes and lots
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

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1270-2020
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1269-2020Class IITerminatedVoluntary: Firm initiated
Z-1270-2020Class IITerminatedVoluntary: Firm initiated