Home / Recalls / Smiths Medical ASD Inc. / Z-0189-2020

Z-0189-2020 Class II Terminated

Recalled by Smiths Medical ASD Inc. — Minneapolis, MN

FDA device recall Z-0189-2020 was initiated by Smiths Medical ASD Inc. on July 8, 2019 and is designated Class II. Reason for recall: Potential for certain GRIPPER Needles to contain an occluded or blocked needle. The recall status is terminated (terminated August 23, 2020). Affected quantity: 3,952,425 devices total.

Recall Details

Product Type: Devices
Report Date: October 30, 2019
Initiation Date: July 8, 2019
Termination Date: August 23, 2020
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 3,952,425 devices total

Product Description

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

Reason for Recall

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

Distribution Pattern

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

Code Information

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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