IVEA Product recall
IVEA Product Part Number 16100 Model 500A
Why was IVEA Product recalled?
The dowel pins (P/N 16082) that fit in the left and right leg pivot castings (P/Ns 16049/16056) can rotate and gradually maneuver out of the leg casting after several hundred deployment and folding cycles (designed for easy storage) of the IVEA unit.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Serial Numbers - 100201, 100251, 100297, 100343, 100390, 100438, 100487, 100666, 100586, 100202, 100252, 100298, 100344, 100391, 100439, 100488, 100667, 100587, 100204, 100253, 100299, 100345, 100392, 100440, 100489, 100507, 100588, 100205, 100254, 100300, 100346, 100393, 100441, 100490, 100508, 100592, 100206, 100255, 100301, 100347, 100394, 100442, 100491, 100509, 100593, 100207, 100256, 100302, 100348, 100395, 100443, 100492, 100510, 100594, 100208, 100257, 100303, 100349, 100396, 100444, 100493, 100511, 100597, 100209, 100258, 100304, 100350, 100397, 100445, 100615, 100512, 100598, 100210, 100259, 100305, 100351, 100398, 100446, 100616, 100513, 100599, 100211, 100260, 100306, 100352, 100399, 100447, 100617, 100515, 100600, 100212, 100261, 100307, 100353, 100401, 100448, 100618, 100516, 100601, 100213, 100262, 100308, 100354, 100402, 100449, 100620, 100520, 100602, 100214, 100263, 100309, 100356, 100403, 100450, 100623, 100522, 100605, 100215, 100264, 100310, 100357, 100404, 100451, 100624, 100524, 100606, 100216, 100265, 100311, 100358, 100405, 100452, 100625, 100525, 100674, 100217, 100266, 100312, 100359, 100406, 100453, 100626, 100528, 100675, 100218, 100267, 100313, 100360, 100407, 100454, 100627, 100530, 100676, 100219, 100268, 100314, 100361, 100408, 100455, 100636, 100532, 100677, 100221, 100269, 100315, 100362, 100409, 100456, 100640, 100534, 100678, 100222, 100270, 100316, 100363, 100410, 100457, 100641, 100538, 100679, 100223, 100271, 100317, 100364, 100411, 100458, 100642, 100544, 100680, 100224, 100272, 100318, 100365, 100412, 100459, 100643, 100545, 100495, 100225, 100273, 100319, 100366, 100413, 100460, 100644, 100546, 100497, 100226, 100274, 100320, 100367, 100414, 100461, 100645, 100547, 100498, 100227, 100275, 100321, 100368, 100415, 100462, 100646, 100548, 100499, 100228, 100276, 100322, 100369, 100416, 100463, 100647, 100549, 100500, 100230, 100277, 100323, 100370, 100417, 100464, 100648, 100550, 100501, 100231, 100278, 100324, 100371, 100418, 100465, 100649, 100551, 100502, 100232, 100279, 100325, 100372, 100419, 100466, 100650, 100552, 100503, 100233, 100280, 100326, 100373, 100420, 100467, 100651, 100553, 100504, 100234, 100281, 100327, 100374, 100421, 100468, 100652, 100554, 100514, 100235, 100282, 100328, 100375, 100422, 100469, 100653, 100556 100519, 100236, 100283, 100329, 100376, 100423, 100472, 100654, 100558, 100521, 100237, 100284, 100330, 100377, 100424, 100474, 100655, 100562, 100523, 100238, 100285, 100331, 100378, 100425, 100475, 100656, 100564, 100526, 100239, 100286, 100332, 100379, 100426, 100476, 100657, 100565, 100527, 100240, 100287, 100333, 100380, 100428, 100477, 100658, 100569, 100529, 100241, 100288, 100334, 100381, 100429, 100478, 100659, 100570, 100531, 100242, 100289, 100335, 100382, 100430, 100479, 100660, 100571, 100533, 100243, 100290, 100336, 100383, 100431, 100480, 100661, 100572, 100535, 100244, 100291, 100337, 100384, 100432, 100481, 100779, 100574, 100536, 100245, 100292, 100338, 100385, 100433, 100482, 100473, 100576, 100537, 100246, 100293, 100339, 100386, 100434, 100483, 100662, 100579, 100539, 100247, 100294, 100340, 100387, 100435, 100484, 100663, 100581, 100540, 100249, 100295, 100341, 100388, 100436, 100485, 100664, 100583, 100541, 100250, 100296, 100342, 100389, 100437, 100486, 100665, 100584, 100542, 100555, 100689, 100736, 100784, 100831, 100878, 100926, 100973, 101021, 100557, 100690, 100737, 100785, 100832, 100879, 100927, 100974, 101022, 100559, 100691, 100738, 100786, 100833, 100880, 100928, 100975, 101023, 100560, 100692, 100739, 100787, 100834, 100881, 100929, 100976, 101024, 100561, 100693, 100740, 100788, 100835, 100882, 100930, 100977, 101025, 100563, 100694, 100741, 100789, 100836, 100883, 100931, 100978, 101026, 100566, 100695, 100742, 100790, 100837, 100884, 100932, 100979, 101027, 100567, 100696, 100743, 100791, 100838, 100885, 100933, 100980, 101028, 100573, 100697, 100744, 100792, 100839, 100886, 100934, 100982, 101029, 100575, 100698, 100745, 100793, 100840, 100887, 100935, 100983, 101030, 100577, 100699, 100746, 100794, 100841, 100888, 100936, 100984, 101040, 100578, 100700, 100747, 100795, 100842, 100889, 100937, 100985, 101041, 100585, 100701, 100748, 100796, 100843, 100890, 100938, 100986, 101042, 100591, 100702, 100749, 100797, 100844, 100891, 100939, 100987, 101043, 100595, 100703, 100750, 100798, 100845, 100892, 100940, 100988, 101044, 100596, 100704, 100751, 100799, 100846, 100893, 100941, 100989, 101045, 100603, 100705, 100752, 100800, 100847, 100894, 100942, 100990, 101046, 100604, 100706, 100753, 100801, 100848, 100895, 100943, 100991, 101047, 100607, 100707, 100754, 100802, 100849, 100896, 100944, 100992, 101048, 100608, 100708, 100755, 100803, 100850, 100897, 100945, 100993, 101049, 100609, 100709, 100756, 100804, 100851, 100898, 100946, 100994, 101050, 100610, 100710, 100757, 100805, 100852, 100899, 100947, 100995, 101051, 100611, 100711, 100758, 100806, 100853, 100900, 100948, 100996, 101052, 100612, 100712, 100759, 100807, 100854, 100901, 100949, 100997, 101053, 100613, 100713, 100760, 100808, 100855, 100902, 100950, 100998, 101054, 100628, 100714, 100761, 100809, 100856, 100903, 100951, 100999, 101055, 100629, 100715, 100762, 100810, 100857, 100904, 100952, 101000, 101056, 100630, 100716, 100763, 100811, 100858, 100905, 100953, 101001, 101057, 100631, 100717, 100764, 100812, 100859, 100906, 100954, 101002, 101058, 100633, 100718, 100765, 100813, 100860, 100907, 100955, 101003, 101059, 100634, 100719, 100766, 100814, 100861, 100908, 100956, 101004, 101060, 100635, 100720, 100767, 100815, 100862, 100910, 100957, 101008, 101061, 100638, 100721, 100768, 100816, 100863, 100911, 100958, 101009, 101062, 100668, 100722, 100769, 100817, 100864, 100912, 100959, 101010, 101063, 100669, 100723, 100770, 100818, 100865, 100913, 100960, 101011, 101064, 100670, 100724, 100771, 100819, 100866, 100914, 100961, 101012, 101065, 100671, 100725, 100772, 100820, 100867, 100915, 100962, 101013, 101066, 100672, 100726, 100773, 100821, 100868, 100916, 100963, 101014, 101067, 100673, 100727, 100774, 100822, 100869, 100917, 100964, 101015, 101068, 100681, 100728, 100775, 100823, 100870, 100918, 100965, 101016, 100682, 100729, 100776, 100824, 100871, 100919, 100966, 101017, 100683, 100730, 100777, 100825, 100872, 100920, 100967, 101018, 100684, 100731, 100778, 100826, 100873, 100921, 100968, 101005, 100685, 100732, 100780, 100827, 100874, 100922, 100969, 101006, 100686, 100733, 100781, 100828, 100875, 100923, 100970, 101007, 100687, 100734, 100782, 100829, 100876, 100924, 100971, 101019, 100688, 100735, 100783, 100830, 100877, 100925, 100972, 101020
- Product
- IVEA Product Part Number 16100 Model 500A
- Recalling firm
- Firefly Medical, Inc.
- Quantity
- 570 units
- Distribution
- United States, Australia, Belgium, Canada, China, Germany, Hong Kong, Indonesia, Israel, Netherlands, Singapore, UAE
- Recall date
- October 11, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)