Z-0189-2020 Class II Terminated
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