Z-0506-2024 Class II Ongoing
FDA device recall Z-0506-2024 was initiated by Liberty Medical Solutions, LLC on November 3, 2023 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 473 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 13, 2023
- Initiation Date
- November 3, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 473 units
Product Description
Multi-Mode Stimulator, Transcutaneous Electrical Nerve Stimulation
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 Pattern
US Nationwide distribution in the states of CT, FL, NC, NJ, NY.
Code Information
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