Smiths Medical ASD Inc.: Medical Device Recall in 2019 - (Recall #: Z-0189-2020)

GRIPPER Needles sold individually. Labeled as the following item descriptions: 1. NDL, GRIPPER, 22G X 1" (25MM), 12/BX; 2. NDL, GRIPPER, 22G X 1.25" (32MM), 12/BX; 3. NDL, GRIPPER, 20G X 1.25" (32MM), 12/BX; 4. NDL, GRIPPER, 19G X 1" (25MM), 12/BX; 5. NDL, GRIPPER, 19G X 1.25" (32MM), 12/BX; 6. NDL, GRIPPER, 22G X .75" (19MM), 12/BX; 7. NDL, GRIPPER, 19G X .75" (19MM), 12/BX; 8. NDL, GRIPPER, 20G X .625" (16MM), 12/BX; 9. NDL, GRIPPER, 22G X .625" (16MM), 12/BX; 10. NDL, GRIPPER PLUS, 22G X 1" (25MM), 12/BX; 11. NDL, GRIPPER PLUS, 22G X 1.25" (32MM), 12/BX; 12. NDL, GRIPPER PLUS, 20G X 1" (25MM) 12/BX; 13. NDL, GRIPPER PLUS, 20G X 1.25" (32MM) 12/BX; 14. NDL, GRIPPER PLUS, 19G X 1" (25MM) 12/BX; 15. NDL, GRIPPER PLUS, 19G X 1.25" (32MM) 12/BX; 16. NDL, GRIPPER PLUS, 22G X .75" (19MM) 12/BX; 17. NDL, GRIPPER PLUS, 20G X .75" (19MM) 12/BX; 18. NDL, GRIPPER PLUS, 19G X .75" (19MM) 12/BX; 19. NDL, GRIPPER PLUS, 20G X .625" (16MM) 12/BX; 20. NDL, GRIPPER PLUS, 22G X .625" (16MM) 12/BX; 21. NDL, GRIPPER PLUS, 22G X .625" (16MM), Y-SITE 12/BX; 22. NDL, GRIPPER PLUS, 22G X .75" (19MM), Y-SITE 12/BX; 23. NDL, GRIPPER PLUS, 22G X 1" (25MM), Y-SITE 12/BX; 24. NDL, GRIPPER PLUS, 22G X 1.25" (32MM), Y-SITE 12/BX; 25. NDL, GRIPPER PLUS, 20G X .625" (16MM), Y-SITE 12/BX; 26. NDL, GRIPPER PLUS, 20G X .75" (19MM), Y-SITE 12/BX; 27. NDL, GRIPPER PLUS, 20G X 1" (25MM), Y-SITE 12/BX; 28. NDL, GRIPPER PLUS, 20G X 1.25" (32MM), Y-SITE 12/BX; 29. NDL, GRIPPER PLUS, 19G X .75" (19MM), Y-SITE 12/BX; 30. NDL, GRIPPER PLUS, 19G X 1" (25MM), Y-SITE 12/BX; 31. NDL, GRIPPER PLUS, 19G X 1.25" (32MM), Y-SITE 12/BX; 32. NDL, GRIPPER, 22G X .625" (16MM), Y-SITE 12/BX; 33. NDL, GRIPPER, 22G X .75" (19MM), Y-SITE 12/BX; 34. NDL, GRIPPER, 22G X 1" (25MM), Y-SITE 12/BX; 35. NDL, GRIPPER, 22G X 1.25" (32MM), Y-SITE 12/BX; 36. NDL, GRIPPER, 20G X .625" (16MM), Y-SITE 12/BX; 37. NDL, GRIPPER, 20G X .75" (19MM), Y-SITE 12/BX; 38. NDL, GRIPPER, 20G X 1" (25MM), Y-SITE 12/BX; 39. NDL, GRIPPER, 20G X 1.25" (32MM), Y-SITE 12/BX; 40. NDL, GRIPPER, 19G X .75" (19MM), Y-SITE 12/BX; 41. NDL, GRIPPER, 19G X 1.25" (32MM), Y-SITE 12/BX; 42. NDL, GRIPPER PLUS, 22G X .625" (16MM), NEEDLELESS Y-SITE 12/BX; 43. NDL, GRIPPER PLUS, 22G X .75" (19MM), NEEDLELESS Y-SITE 12/BX; 44. NDL, GRIPPER PLUS, 22G X 1" (25MM), NEEDLELESS Y-SITE 12/BX; 45. NDL, GRIPPER PLUS, 20G X .625" (16MM), NEEDLESS Y-SITE 12/BX; 46. NDL, GRIPPER PLUS, 20G X .75" (19MM), NEEDLELESS Y-SITE 12/BX; 47. NDL, GRIPPER PLUS, 20G X 1" (25MM), NEEDLELESS Y-SITE 12/BX; 48. NDL, GRIPPER PLUS, 20G X 1.25" (32MM), NEEDLELESS Y-SITE 12/BX; 49. NDL, GRIPPER PLUS, 19G X .75" (19MM), NEEDLELESS Y-SITE 12/BX; 50. NDL, GRIPPER PLUS, 19G X 1" (25MM), NEEDLELESS Y-SITE 12/BX; 51. NDL, GRIPPER PLUS, 19G X 1.25" (32MM), NEEDLELESS Y-SITE 12/BX; 52. NDL, GRIPPER MICRO, 22G X .75 12/BOX; 53. NDL, GRIPPER MICRO, 22G X 1" 12/BOX; 54. NDL, GRIPPER MICRO, 22G X 1.25" 12/BOX; 55. NDL, GRIPPER MICRO, 20G X .75" 12/BOX; 56. NDL, GRIPPER MICRO, 20G X 1" 12/BOX; 57. NDL, GRIPPER MICRO, 20G X 1.25" 12/BOX; 58. NDL, GRIPPER MICRO, 19G X .75" 12/BOX; 59. NDL, GRIPPER MICRO, 19G X 1" 12/BOX; 60. NDL, GRIPPER MICRO, 19G X 1.25" 12/BOX; 61. NDL, GRIPPER MICRO, 22G X .75", LUER ACTIVATED NEEDLELESS Y-SITE 12/BOX; 62. NDL, GRIPPER MICRO, 22G X 1", LUER ACTIVATED NEEDLELESS Y-SITE 12/BOX; 63. NDL, GRIPPER MICRO, 22G X 1.25", NAC Y-SITE 12/BOX; 64. NDL, GRIPPER MICRO, 20G X .75", LUER ACTIVATED NEEDLELESS Y-SITE 12/BOX; 65. ND

Class II

Potential for certain GRIPPER Needles to contain an occluded or blocked needle.

1. Item Number 21-2714-24, Lot Numbers: 3655327, 3666475, 3671671, 3674631, 3675844, 3715667, 3716111, 3725093, 3731211, 3749579, 3749580, 3749581, 3769909; 2. Item Number 21-2715-24, Lot Numbers: 3674630, 3675843, 3677350, 3716110, 3725091, 3749585, 3770701; 3. Item Number 21-2718-24, Lot Numbers: 3655323, 3666473, 3674621, 3675834, 3677353, 3716102, 3725089, 3740631, 3757107, 3770693; 4. Item Number 21-2720-24, Lot Numbers: 3655322, 3675832, 3675833, 3716101, 3749587, 3770692; 5. Item Number 21-2721-24, Lot Numbers: 3666452, 3675830, 3675831, 3715665, 3725088, 3731205, 3736849, 3740630, 3770691; 6. Item Number 21-2733-24, Lot Numbers: 3660302, 3662983, 3666451, 3671657, 3674620, 3675825, 3675826, 3675828, 3677354, 3716083, 3716085, 3725084, 3725085, 3740613, 3740614, 3749588, 3770685; 7. Item Number 21-2735-24, Lot Number 3666448, 3674618, 3675817, 3716071, 3721132, 3736842, 3740608, 3757100, 3770682; 8. Item Number 21-2736-24, Lot Numbers: 3660301, 3662981, 3674605, 3675812, 3675813, 3716069, 3721130, 3736841, 3757099, 3770669; 9. Item Number 21-2737-24, Lot Numbers: 3666447, 3675809, 3675810, 3725083, 3736840, 3749591, 3757097, 3770665; 10. Item Number 21-2760-24, Lot Numbers: 3674592, 3675803, 3675805, 3675807, 3725081, 3731191, 3736838, 3740605, 3749593, 3757094, 3757096, 3770658, 3770659, 3770660; 11. Item Number 21-2761-24, Lot Numbers: 3655317, 3662979, 3671635, 3675801, 3721127, 3725080, 3731190, 3740603, 3740604, 3757093, 3770657; 12. Item Number 21-2762-24, Lot Numbers: 3628112, 3644124, 3653181, 3660300, 3666444, 3674569, 3675797, 3675798, 3675799, 3722887, 3722888, 3725079, 3731181, 3736835, 3740602, 3749594, 3757089, 3757092, 3770651, 3770653; 13. Item Number 21-2763-24, Lot Numbers: 3653180, 3666442, 3674556, 3675791, 3675792, 3675793, 3731177, 3731178, 3731179, 3757088, 3770647; 14. Item Number 21-2764-24, Lot Numbers: 3653176, 3655311, 3662978, 3666441, 3671629, 3675788, 3675789, 3675790, 3721125, 3725075, 3736830, 3740599, 3749596, 3757087, 3770641, 3770642, 3770643; 15. Item Number 21-2765-24, Lot Numbers 3675785, 3675786, 3721123, 3725073, 3725074, 3731176, 3740596, 3740597; 16. Item Number 21-2766-24, Lot Numbers: 3653175, 3655310, 3666439, 3671594, 3675782, 3675783, 3721115, 3725071, 3736824, 3736826, 3736828, 3749600, 3757084, 3757085, 3770630, 3770632, 3770633; 17. Item Number 21-2767-24, Lot Numbers: 3644121, 3653172, 3653173, 3655307, 3660294, 3671592, 3671593, 3675781, 3757081, 3757082, 3757083, 3770622, 3770625; 18. Item Number 21-2768-24, Lot Numbers: 3666421, 3674552, 3675773, 3675774, 3675775, 3721087, 3725064, 3731172, 3731173, 3736809, 3736811, 3749608, 3749609, 3757079, 3770617, 3770620; 19. Item Number 21-2769-24, Lot Numbers: 3628103, 3653167, 3655306, 3660293, 3666419, 3671590, 3675769, 3675770, 3721081, 3725061, 3725062, 3731171, 3736807, 3736808, 3749611, 3749620, 3749621, 3757076, 3757077, 3770612; 20. Item Number 21-2770-24, Lot Numbers: 3644117, 3644118, 3660292, 3671589, 3674529, 3675764, 3675765, 3675766, 3722890, 3722892, 3731169, 3736804, 3740561, 3749622, 3757075, 3770605; 21. Item Number 21-2860-24, Lot Numbers: 3653165, 3662976, 3675762, 3675763, 3677382, 3749624, 3757073, 3770599; 22. Item Number 21-2861-24, Lot Numbers: 3653163, 3653164, 3671585, 3671586, 3674476, 3675759, 3675760, 3675761, 3718794, 3725057, 3731167, 3736803, 3740554, 3749625, 3757070, 3770595, 3770596, 3770597; 23. Item Number 21-2862-24, Lot Numbers: 3653162, 3655305, 3662975, 3666417, 3675758, 3677384, 3718789, 3719924, 3731163, 3731164, 3736801, 3740552, 3749627, 3770590, 3770591; 24. Item Number 21-2863-24, Lot Numbers: 3655304, 3671584, 3675756, 3718765, 3736799, 3749628, 3770589; 25. Item Number 21-2864-24, Lot Numbers: 3644113, 3653161, 3666411, 3671583, 3675754, 3675755, 3677386, 3725050, 3731162, 3736797, 3748515, 3770587; 26. Item Number 21-2865-24, Lot Numbers: 3653160, 3662974, 3671582, 3674341, 3675751, 3675752, 3675753, 3718788, 3725047, 3725048, 3725049, 3731160, 3731161, 3736795, 3740545, 3748513, 3757067, 3757068, 3770582, 3770583, 3770584; 27. Item Number 21-2866-24, Lot Numbers: 3644111, 3655296, 3666404, 3671581, 3675747, 3675749, 3675750, 3718783, 3719921, 3725044, 3725046, 3736794, 3740543, 3748512, 3757065, 3757066, 3770575, 3770576, 3770577; 28. Item Number 21-2867-24, Lot Numbers: 3660268, 3666403, 3674188, 3675746, 3719919, 3725043, 3731156, 3736792, 3740539, 3748511, 3757063, 3770573; 29. Item Number 21-2868-24, Lot Numbers: 3660266, 3666402, 3675742, 3675743, 3675744, 3719918, 3725040, 3725041, 3731152, 3731155, 3736790, 3740537, 3748507, 3748508, 3757061, 3770569, 3770570; 30. Item Number 21-2869-24, Lot Numbers: 3666401, 3675739, 3675740, 3675741, 3718771, 3725034, 3725036, 3731151, 3736787, 3740535, 3748506; 31. Item Number 21-2870-24, Lot Numbers: 3655295, 3662971, 3666400, 3675698, 3718766, 3725031, 3725032, 3736785, 3748504; 32. Item Number 21-2938-24, Lot Numbers: 3674151, 3675694, 3675695, 3757059, 3770544; 33. Item Number 21-2939-24, Lot Numbers: 3660265, 3666399, 3671580, 3675691, 3675692, 3675693, 3677387, 3716061, 3719916, 3725030, 3740167, 3748498, 3749629, 3757058, 3770537, 3770542; 34. Item Number 21-2940-24, Lot Numbers: 3666398, 3671579, 3674150, 3675687, 3675688, 3716059, 3719913, 3725015, 3736782, 3748497, 3749630, 3770530, 3770532; 35. Item Number 21-2941-24, Lot Numbers: 3660264, 3674148, 3675685, 3716057, 3736781, 3749631; 36. Item Number 21-2946-24, Lot Numbers: 3662970, 3666396, 3674147, 3675680, 3740163, 3770527; 37. Item Number 21-2947-24, Lot Numbers: 3655291, 3666395, 3674146, 3675675, 3675676, 3675677, 3716053, 3716055, 3719901, 3725011, 3725012, 3725013, 3731150, 3736777, 3736779, 3740529, 3748495, 3757056, 3770522; 38. Item Number 21-2948-24, Lot Numbers: 3662966, 3662968, 3671571, 3674144, 3674145, 3675656, 3675657, 3675661, 3716016, 3725007, 3725009, 3731148, 3740162, 3748492, 3757051, 3757054, 3770502, 3770505; 39. Item Number 21-2949-24, Lot Numbers: 3655290, 3662965, 3674143, 3675647, 3675648, 3675649, 3731145, 3757048, 3770497, 3770499; 40. Item Number 21-2955-24, Lot Numbers: 3660254, 3675643, 3675644, 3757047, 3770488, 3770489; 41. Item Number 21-2957-24, Lot Numbers: 3655289, 3662963, 3675636, 3675638, 3736776, 3757045; 42. Item Number 21-2960-24, Lot Numbers: 3653137, 3660243, 3666393, 3675635, 3677394, 3740160, 3748491, 3749634; 43. Item Number 21-2961-24, Lot Numbers: 3655288, 3662962, 3666391, 3674138, 3677395, 3740158, 3748489, 3757041, 3757042, 3770479, 3770480, 3770481; 44. Item Number 21-2962-24, Lot Numbers: 3675628, 3675629, 3719897, 3731077, 3731078, 3740156, 3748486, 3757040; 45. Item Number 21-2964-24, Lot Numbers: 3644096, 3653135, 3660242, 3671566, 3674135, 3675623, 3712296, 3725004, 3725005, 3748485; 46. Item Number 21-2965-24, Lot Numbers: 3653134, 3655287, 3662961, 3666390, 3671565, 3674130, 3675618, 3675619, 3675620, 3712518, 3715979, 3719895, 3725001, 3725002, 3736771, 3740153, 3740154, 3748482, 3749636, 3757038, 3769880, 3769881, 3769884, 3769887; 47. Item Number 21-2966-24, Lot Numbers: 3653133, 3655286, 3660240, 3662960, 3671564, 3677398, 3712516, 3714560, 3719894, 3725000, 3736770, 3740142, 3748476, 3748481, 3749637, 3757036, 3770464, 3770468; 48. Item Number 21-2967-24, Lot Numbers: 3653132, 3671560, 3675373, 3719893, 3731075, 3731076, 3757034, 3770458, 3770459; 49. Item Number 21-2968-24, Lot Numbers: 3655284, 3662958, 3671545, 3674127, 3675734, 3675735, 3675736, 3677399, 3711486, 3711487, 3719892, 3724998, 3724999, 3731074, 3736768, 3748473, 3748474, 3749638, 3770451, 3770453, 3770455; 50. Item Number 21-2969-24, Lot Numbers: 3666385, 3675356, 3675357, 3677400, 3724997, 3731069, 3736765, 3740136, 3748471, 3757031, 3770445; 51. Item Number 21-2970-24, Lot Number: 3674126; 52. Item Number 21-3251-24, Lot Numbers: 3653130, 3653131, 3660232, 3671536, 3674125, 3675733, 3712515, 3719888, 3731067, 3736764, 3740135, 3748468, 3748469, 3757029, 3770438; 53. Item Number 21-3252-24, Lot Numbers: 3660230, 3671535, 3674121, 3675731, 3724996, 3736763, 3740134; 54. Item Number 21-3253-24, Lot Numbers: 3636974, 3653128, 3677402, 3740133; 55. Item Number 21-3256-24, Lot Numbers: 3640469, 3644089, 3653126, 3660228, 3671534, 3674120, 3675349, 3675729, 3675730, 3724995, 3731065, 3736709, 3740132, 3748463, 3748466, 3757026, 3757027, 3770429; 56. Item Number 21-3257-24, Lot Numbers: 3644088, 3653124, 3666379, 3674119, 3675727, 3675728, 3677403, 3731063, 3736706, 3740130, 3748462, 3749639, 3757025; 57. Item Number 21-3258-24, Lot Numbers: 3655283, 3671531, 3675342, 3677404, 3711488, 3712507, 3770427; 58. Item Number 21-3260-24, Lot Numbers: 3628080, 3653123, 3655282, 3662956, 3666378, 3671530, 3675724, 3675725, 3712503, 3712504, 3757023, 3757024, 3770426; 59. Item Number 21-3261-24, Lot Numbers: 3653122, 3662955, 3666376, 3675337, 3677405, 3724993, 3731062, 3748460, 3749658, 3757022, 3770421, 3770423; 60. Item Number 21-3262-24, Lot Numbers: 3653121, 3666375, 3675721; 61. Item Number 21-3271-24, Lot Numbers: 3644072, 3653119, 3653120, 3660226, 3666374, 3671529, 3674117, 3675722, 3677406, 3712963, 3724991, 3740117, 3740118, 3748458, 3749660; 62. Item Number 21-3272-24, Lot Numbers: 3653118, 3711489, 3719886, 3731061, 3736702; 63. Item Number 21-3273-24, Lot Number: 3712501; 64. Item Number 21-3276-24, Lot Numbers: 3675717, 3675719, 3712965, 3715972, 3719885, 3724990, 3740107, 3740111, 3748455, 3749662, 3757021, 3770388; 65. Item Number 21-3277-24, Lot Numbers: 3640466, 3644069, 3653113, 3660217, 3666373, 3675328, 3677407, 3712967, 3731059, 3731060, 3740105, 3748452, 3749665; 66. Item Number 21-3278-24, Lot Numbers: 3653111, 3666372, 3675326, 3712968; 67. Item Number 21-3280-24, Lot Numbers: 3644068, 3675324, 3675325, 3712969, 3731057, 3736696, 3748449, 3749668, 3770381; 68. Item Number 21-3281-24, Lot Numbers: 3653109, 3660215, 3674112, 3675716; 69. Item Number 21-3282-24, Lot Numbers: 3712313, 3715970, 3748447; 70. Item Number 21-3362-24, Lot Numbers: 3644064, 3644065, 3662951, 3671523, 3674111, 3675713, 3675714, 3675715, 3714646, 3719884, 3731053, 3736693, 3740095, 3748444, 3748445, 3748446, 3757013, 3770375; 71. Item Number 21-3363-24, Lot Numbers: 3653108, 3666367, 3674998, 3714643, 3715967, 3740094, 3749675, 3757011, 3770258; 72. Item Number 21-3364-24, Lot Numbers: 3644063, 3660205, 3671521, 3674994, 3674995, 3674996, 3674997, 3714642, 3715964, 3724986, 3731051, 3740065, 3740066, 3748443, 3757008, 3757009, 3770171, 3770173, 3770175; 73. Item Number 21-3365-24, Lot Numbers: 3660204, 3674992, 3674993, 3714641, 3719883, 3724984, 3736685, 3740064, 3757001, 3769911, 3769912; 74. Item Number 21-3367-24, Lot Numbers: 3653105, 3655279, 3660203, 3666363, 3671519, 3674110, 3675709, 3675710, 3675711, 3714638, 3714639, 3714640, 3719879, 3724978, 3731047, 3731048, 3736678, 3748435, 3749680, 3756996, 3756997, 3770166, 3770169; 75. Item Number 21-3368-24, Lot Numbers: 3655275, 3655277, 3662950, 3674109, 3675705, 3675706, 3675707, 3731045, 3731046, 3736675, 3740061, 3748432, 3756992, 3756993, 3770160, 3770161; 76. Item Number 21-3369-24, Lot Numbers: 3628069, 3653101, 3662947, 3674107, 3674981, 3674983, 3736666, 3736667, 3740059, 3748427, 3748429, 3756991, 3769915, 3769917; 77. Item Number 21-3464-24, Lot Numbers: 3628067, 3653053, 3655274, 3666360, 3674979, 3674980; 78. Item Number 21-3465-24, Lot Numbers: 3653051, 3660201, 3662946, 3666353, 3674106, 3675699, 3675701, 3677408, 3714637, 3715961, 3724977, 3731042, 3736663, 3740057, 3748422, 3748424, 3756989, 3756990, 3770039, 3770040; 79. Item Number 21-3466-24, Lot Numbers: 3653048, 3653050, 3674972, 3674973, 3674974, 3674975, 3677409, 3714635, 3715955, 3719876, 3724976, 3731041, 3740051, 3740052, 3748408, 3749687, 3756987, 3770035, 3770037; 80. Item Number 21-3467-24, Lot Numbers: 3655273, 3671517, 3674971, 3714634, 3715956, 3731040; 81. Item Number 21-3468-24, Lot Numbers: 3655271, 3662944, 3666345, 3671505, 3674969, 3674970, 3714632, 3714633, 3715958, 3740048, 3740049, 3748407, 3756986, 3770028, 3770030; 82. Item Number 21-3469-24, Lot Numbers: 3655270, 3660200, 3671504, 3674966, 3674967, 3674968, 3740047, 3769925, 3769927

Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, PR. International distribution

Voluntary: Firm initiated