Multi-Mode Stimulator, Transcutaneous Electrical Nerve Stimulation
This recall is currently active, issued December 7, 2023. It was issued by Liberty Medical Solutions, Llc.
- Company
- Liberty Medical Solutions, Llc
- Recall Initiated
- November 3, 2023
- Posted
- December 7, 2023
- Recall Number
- Z-0506-2024
- Quantity
- 473 units
- Firm Location
- Tampa, FL
- Official Source
- View on FDA website ↗
Reason for Recall
The instruction manuals that were included with the Multi-Mode Stimulators distributed from 2018 to 2023 did not contain all of the appropriate warnings and contraindications.
Distribution
US Nationwide distribution in the states of CT, FL, NC, NJ, NY.
Lot / Code Info
UDI/DI 00860000178303, Serial Numbers: 181102627, 180101759, 180302368, 180603258, 180101748, 180603502, 160700386, 170305821, 170305701, 180603845, SZ151100022, 180603489, SZ160801811, 180603829, 151100395, 180101912, 181102643, 160800430, 180603799, 160800489, 181102635, 181102714, 180302357, 181102642, 161202284, 160800483, 180603914, 180101917, 161202293, 161202285, 181102649, 160107765, 180603065, 180603924, SZ160502068, 180603841, 180603864, 160800092, 180603059, 160800417, SZ160700097, 170305806, 160800493, 161202287, 181102646, 181102789, 180101911, SZ151100005, 180603839, SZ151100017, 181102803, 180101738, 160800429, 180302376, 180603041, 160800508, 180603958, 180603965, 180603822, 180603244, 181102787, 180603824, 180603828, 160800420, 180603855, 180302345, 180603057, 181102794, 181102636, 181102790, 180603066, 180302348, 181102795, 170305704, 161202288, 1801102713, 180603821, 180603921, 7141000961, 180603261, 160800091, 181102710, 161202286, SZ160502080, 160800093, 180603843, 181102709, 160800439, 180603927, 170305819, 180603867, 170305716, 180302366, 181102800, 181102798, 180603941, 170305815, 180603817, 180603865, 160800066, 180603493, 180603505, 181102791, 181102653, SZ150900502, 180603061, 180603260, 181102647, 180603053, 180603814, 180603067, 180603496, 180603255, SZ160700100, 180603495, 160800485, 181102804, 151100129, 181102698, 180603498, 181102690, 180603801, 160800498, 160800083, 181102693, 180603058, 180603962, 161202274, SZ151100032, 181102281, 160800418, 180603967, 180603787, 180603506, 161202282, 180603050, 180101920, 181102637, 180603253, 170305813, 181102628, 180603849, 180101916, 160800427, 180603832, 160107764, 180603866, 180603503, 181102638, 180603851, 180603064, 180603262, 180603242, 180603923, 181102703, 181102720, 170305798, 170305800, 180302351, 180603500, SZ160801822, 181102634, 180302373, 180603051, 160800486, SZ150900361, 170305807, 180603942, 161202291, 180603811, 160107762, 181102813, 160700121, 160800506, 170305804, 180101900, 180302370, 160800504, 160800505, 180603818, 181102692, 180101739, 161202298, 181102633, 180603809, 180603823, 180603870, 180603263, 161202290, 160800419, 180603908, 170305816, 161202275, 180603256, SZ160801801, SZ150900357, SZ150900367, 170305721, 180603836, 170305707, 170305728, 180603848, 180603922, 180302353, 180603497, 180101924, 170305794, 170305818, 180603857, 180101894, 160107746, 180603054, 180302362, 160800490, 180603871, 180101752, 180603055, 180302365, 160800497, 180603802, 181102719, 170305715, 160800495, 170305699, 160800069, 181102625, 180603943, 180603838, 180101922, 181102655, 180603790, 170305812, 181102274, 180603952, SZ150900400, 180603778, 160800425, 180101741, 181102788, 180603834, 180603264, 180101762, 160800075, 180603813, 160107747, 160800068, 160800441, 180101750, 181102629, 160800079, 181102283, 170305811, 170305822, 180603957, 181102792, 180603062, 180603243, 180603069, 170305802, 160800436, 180603785, 180101753, 180101923, 170305697, 181102785, 180603064, 170305702, 160800496, SZ160801803, 180603507, 160800094, 160700398, 160800481, 181102689, 160800487, 180603517, 160800492, 170305714, 180603490, 181102651, 180302371, 160800072, 180603511, 170305801, 180603816, 180603045, 180603919, 180603963, SZ151100151, 180603060, 160800424, 180603257, SZ160700098, 160800434, 180603847, 181102808, 180603826, 160800439, 180603960, 160800432, 160800510, 170305810, 180603868, 180603800, 180603869, 161202273, 180603860, SZ150900359, 180603807, SZ151100001, 180603806, 180101763, 181102699, 180101907, 180603931, 160800421, 181102640, 180603861, 181102717, 180302347, 160800428, 180603844, 170305727, 170305705, 180603930, 180603951, 160700407, 160800423, 170305706, 170305803, 180302352, 170305795, 180603046, 181102707, 180302369, 180603794, 160800080, 170305719, 180603792, 180603240, 181102797, 160800065, 181102701, 170305698, 181102814, 180603049, 180603510, 180603825, 180302367, 181102718, 180603494, SZ150900377, 180603044, 181102626, 181102716, 160800442, SZ160801808, SZ160502058, 180101921, 180603929, 170305809, 160800512, 180603246, 180101757, 180603803, 170305720, 160800096, 170305797, 180603254, 181102811, 180603513, 180101901, 180603831, SZ150900353, 180603910, SZ160801810, SZ160700399, 160800067, 180603048, 160800509, 160107752, 180603842, 170305799, 170305708, SZ160700386, 180603872, 180101747, 181102632, 160800070, 180603786, 180101736, 181102816, 180101902, 181102712, 180603072, 181102799, 160800484, 180603798, 160801816, 180603846, 180603820, 170305817, 180603926, 180302360, 150900416, 181102695, 181102812, 160800482, 181102645, 160800502, 180603797, 180603514, 180603966, 160800076, 160800488, 180302346, 170305823, 180603499, 180302350, 181102648, 180603955, 170305814, 180101893, 181102704, 180603376, 180603518, 180603043, 180603859, 180603252, 180603375, 180603830, 180603856, 180603840, 180603949, 180302349, 180603783, 180101734, 181102631, 180603516, 170305808, 160800426, 170305712, 180603808, 180603259, SZ150900354, 181102639, 180603835, 160800438, 170305820, 180603804, 180603070, 181102644, 181102802, 180603850, 181102697, 181102786, 180603784, 180101905, 160800494, 181102650, 180302359, 180603964, 160107772, 180603833, 180603912, 180101895, 181102700, 170305805, 180603515, 181102641, 180603862, 180101897, 180603944
Root Cause
Error in labeling
Action Taken
Liberty Medical Solutions, LLC issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 11/03/2023 via US Mail. The notice explained the problem and provided an updated instruction manual.