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Medium RiskFDA Device

Smiths Medical ASD Inc.: Potential for certain GRIPPER Needles to contain an occluded or blocked needle.

Agency Publication Date: October 24, 2019
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Affected Products

Product: 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" (1

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

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Product: GRIPPER Needles sold as part of PORT-A-CATH II SINGLE LUMEN SYSTEM. Labeled as the following item descriptions: 1. TRAY, PAC, VEN, TI, PU, 1.9MM, UL, 6FR/INTRO 1/EA; 2. TRAY, PAC, VEN LP, TI, PU, 1.9MM, UL, 6 FR/INTRO 1/EA; 3. TRAY, PAC II, VEN, 2.8MM, CS, 9FR/INTRO 1/EA; 4. TRAY, PAC II, VEN, TI, PU, 1.9MM, UL, 6FR/INTRO 1/EA; 5. TRAY, PAC II, VEN, PU, 2.6MM, UL, 8.5FR/INTRO 1/EA; 6. TRAY, PAC II, VEN, PU, 2.6MM, PRE-AY, 8.5FR/INTRO 1/EA;

1. Item Number 21-4025-24, Lot Numbers 3674105, 3694006, 3712500, 3736641, 3748406, 3756975; 2. Item Number 21-4037-24, Lot Numbers 3659767, 3674101, 3690401, 3694005, 3703706, 3709205, 3731036, 3765362; 3. Item Number 21-4051-24, Lot Number: 3624979; 4. Item Number 21-4053-24, Lot Number 3659766, 3662933, 3731032; 5. Item Number 21-4055-24, Lot Numbers: 3683539, 3690396, 3690397, 3703705, 3709204, 3712498, 3717709, 3736577, 3748401, 3756973, 3765356, 3765357, 3765358, 3765360; 6. Item Number 21-4065-24, Lot Number: 3668869; 7. Item Number 21-4068-24, Lot Number: 3749691; 8. Item Number 21-4069-24, Lot Number: 3765354; 9. Item Number 21-4071-24, Lot Numbers: 3618196, 3740043; 10. Item Number 21-4073-24, Lot Numbers: 3687796, 3690395, 3731024, 3736575; 11. Item Number 21-4083-24, Lot Numbers: 3662930, 3662931, 3662932, 3756971, 3765346, 3765348; 12. Item Number 21-4153-24, Lot Numbers: 3628064, 3674098; 13. Item Number 21-4155-24, Lot Numbers: 3659764, 3674097, 3687795, 3717706, 3736572, 3776589; 14. Item Number 21-4171-24, Lot Numbers: 3696520, 3709202, 3772784; 15. Item Number 21-4183-24, Lot Numbers: 3731023, 3736569, 3756970; 16. Item Number 21-4187-24, Lot Numbers: 3756969, 3772751; 17. Item Number 21-4423-24, Lot Numbers: 3659762, 3662929, 3666142, 3756968, 3765344; 18. Item Number 21-4425-24, Lot Numbers: 3696519, 3717705, 3736566; 19. Item Number 21-4437-24, Lot Numbers: 3655263, 3666141, 3683517, 3694001, 3724970, 3730962, 3748385, 3748386, 3756965; 20. Item Number 21-4453-24, Lot Numbers: 3659761, 3662927, 3712497, 3730960, 3736565, 3748382, 3749695, 3765338; 21. Item Number 21-4455-24, Lot Numbers: 3643998, 3662926, 3666139, 3671489, 3674096, 3687793, 3690392, 3696517, 3703702, 3706172, 3712495, 3730957, 3736563, 3740039, 3748380, 3756963, 3772703; 22. Item Number 21-4465-24, Lot Numbers: 3655261, 3693997, 3736554; 23. Item Number 21-4471-24, Lot Numbers: 3703701, 3717695, 3717696, 3730951, 3730952, 3756958; 24. Item Number 21-4474-24, Lot Numbers: 3666137, 3765332; 25. Item Number 21-4475-24, Lot Numbers: 3655257, 3666126, 3709201, 3717694, 3736553, 3740036, 3756957, 3765329, 3765330; 26. Item Number 21-4476-24, Lot Numbers: 3655256, 3659759; 27. Item Number 21-4477-24, Lot Numbers: 3655255, 3674095, 3687791, 3690388, 3703700, 3706171, 3709200, 3719958, 3730948, 3740035, 3748373, 3756954; 28. Item Number 21-4483-24, Lot Numbers: 3655254, 3669980, 3679144, 3690385, 3690386, 3696515, 3703678, 3706170, 3730946, 3736551, 3740034, 3749697, 3756952; 29. Item Number 21-4485-24, Lot Numbers: 3679481, 3683507; 30. Item Number 21-4873-24, Lot Numbers: 3655242, 3659737, 3693996, 3706169, 3730945, 3748364, 3756946; 31. Item Number 21-8066-24, Lot Number: 3756945; 32. Item Number 21-8466-24, Lot Numbers: 3662921 ,3730943, 3756938; 33. Item Number 21-8468-24, Lot Numbers: 3659735, 3666104, 3765319; 34. Item Number 21-8470-24, Lot Numbers: 3655234, 3666103, 3696513, 3730942

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Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 83286
Status: Resolved
Manufacturer: Smiths Medical ASD Inc.
Manufactured In: United States
Units Affected: 2 products (3,952,425 devices total; 3,952,509 devices total)

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.