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Devices
Device Recall Paradigm Silouette Infusion SetThe Silouette Infusion Set
Model / Serial
5031734, 5034234, 5034311, 5035640, 5036333, 5037019, 5037922, 5037923, 5039570, 5040033, 5040162, 5040476, 5041194, 5043391, 5043392, 5046554, 5047941, 5048106, 5048106, 5049985, 5051351, 5052913, 5053724, 5054982, 5056181, 5056651, 5057784, 5059432, 5059299, 5059931, 5064182, 5064183, 5064848, 5064849, 5066434, 5066634, 5967602, 5067603, 5076272, 5032622, 5032758, 5034233, 5034310, 5035639, 5037920, 5037921, 5037930, 5039572, 5040161, 5043390, 5046552, 5048407, 5050059, 5051349, 5051349, 5066394, 5067601, 5075676, 5032623, 5038026, 5038063, 5038064, 5038065, 5040032, 5040475, 5049408, 5042573, 5044092, 5048408, 5049833, 5051350, 5052912, 5053723, 5057783, 5058431, 5059298, 5061640, 5070165, 5072741, 5031735, 5031736, 5032662, 5032663, 5034236, 5035643. 5035644, 5037021, 5038839, 5039986, 5039987, 5040035, 5040163, 5042478, 5042575, 5042576, 5042714, 5042715, 5043393, 5046462, 5046463, 5046558, 5047107, 5047491, 5047942, 5047943, 5050056, 5050057, 5051352, 5051353, 5051354, 5057791, 5058433, 5059933, 5061646, 5061670, 5061967, 5063527, 5063528, 5063628, 5066395, 5067505, 5067604, 5067605, 5070166, 5070833, 5070834, 5072351, 5030865, 5031737, 5031738, 5032665, 5032670, 5032671, 5032759, 5032760, 5033423, 5033424, 5034312, 5034313, 5034314, 5034315, 5034316, 5036334, 5038842, 5038843, 5039574, 5039988, 5039989, 5039990, 5039991, 5039992, 5039993, 5040164, 5040165, 5041846, 5041847, 5041848, 5041855, 5041856, 5042469, 5042470, 5042471, 5042549, 5042550, 5042592, 5042593, 5043394, 5043395, 5043396, 5043397, 5043398, 5043399, 5043400, 5042548, 5046464, 5046465, 5046560, 5046561, 5046562, 5046563, 5047497, 5047498, 5048108, 5048409, 5048410, 5049133, 5049134, 5049568, 5049569, 5049570, 5050058, 5051355, 5051356, 5051357, 5051358, 5052914, 5053725, 5053726, 5054287, 5054288, 5055346, 5055347, 5055389, 5055390, 5055391, 5059936, 5056165, 5056167, 5056174, 5057107, 5057108, 5057785, 5057786, 5058434, 5058435, 5058436, 5059300, 5059301, 5059302, 5059934, 5059935, 5059937, 5060839, 5060840, 5060841, 5061641, 5063529, 5063530, 5063531, 5063532, 5064184, 5064185, 5064852, 5064853, 5064854, 5064855, 5065534, 5065535, 5066616, 5066630, 5066631, 5066632, 5066633, 5067481, 5067606, 5067607, 5070167, 5070168, 5070835, 5070836, 5072352, 5072353, 5072354, 5073123, 5075677, 5076273, 5076274, 5046566, 5031739, 5031740, 5031741, 5031742, 5032656, 5032657, 5032761, 5032762, 5033425, 5033426, 5034237, 5034317, 5034318, 5034319, 5034320, 5034321, 5035645, 5035708, 5035709, 5035710, 5036335, 5037022, 6037924, 5037925, 5037926, 5037927, 5038849, 5038850, 5040036, 5040037, 5040038, 5040166, 5040167, 5040168, 5041849, 5041850, 5041851, 5041852, 5041853, 5041854, 5042472, 5042473, 5043407, 5042555, 5042562, 5043401, 5043402, 5043403, 5043404, 5043405, 5043406, 5043408, 5044098, 5044099, 5044100, 5044101, 5044102, 5046403, 5046404, 5046405, 5046564, 5046565, 5046566, 5046567, 5047503, 5047504, 5047505, 5047506, 5048411, 5048412, 5048413, 5049550, 5049552, 5049553, 5049554, 5049555, 5049561, 5049562, 5049838, 5049839, 5051359, 5051360, 5051361, 5051362, 5051363, 5051364, 5052915, 5052916, 5053727, 5053728, 5053729, 5053730, 5055336, 5055337, 5055338, 5055339, 5055392, 5055892, 5055893, 5055894, 5055899, 5055906, 5055907, 5055908, 5056652, 5056653, 5056654, 5056655, 5057109, 5057110, 5057787, 5057788, 5058437, 5058438, 5059303, 5059304, 5055900, 5059938, 5059939, 5059940, 5059941, 5060842, 5060843, 5060844, 5061642, 5061643, 5061644, 5061645, 5064186, 5064187, 5064188, 5064189, 5064190, 5065856, 5064857, 5065536, 5065537, 5065538, 5066396, 5066397, 5066398, 5066433, 5066501, 5066552, 5066645, 5066646, 5066647, 5067488, 5067489, 5067491, 5067492, 5067498, 5067594, 5067595, 5067596, 5067597, 5067598, 5067599, 5067600, 5070169, 5070170, 5070171, 5070837, 5072355, 5072356, 5072742, 5072743, 5072744, 5072745, 5076275, 5076276, 5076277, 5076278, 5076279, 5043409, 5032628, 5032763, 5034322, 5034323, 5038030, 5038069, 5038070, 5038071, 5040039, 5040169, 5042569, 5042571, 5042572, 5042716, 5042717, 5043409, 5043410, 5046568, 5048110, 5051365, 5052917, 5053731, 5054289, 5055811, 5055813, 5055989, 5057111, 5057789, 5058439, 5059305, 5059942, 5060845, 5060846, 5063533, 5063534, 5063535, 5063534, 5063629, 5067608, 5067609, 5067610, 5076280, 5076281, 5028970, 5030872, 5033532, 5034324, 5037929, 5042480, 5042718, 5046570, 5047123, 5048111, 5049988, 5050061, 5052918, 5055809, 5055988, 5056656, 5057790, 5058440, 5059306, 5059943, 5064858, 5066432, 5066652, 5067385, 5070838, 5073131, 5076282, 5032630, 5038025, 5038072, 5038073, 5042577, 5043411, 5046406, 5049989, 5051366, 5057112, 5058710, 5067386, 5073132, 5075678, 5076283,
Product Classification
General Hospital and Personal Use Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - US including CA, IN, PA, and Internationally to Canada, Korea, and Japan.
Product Description
Silhouette Paradigm 13mm, 18"; Silhouette 43"; Silhouette 23"; Silhouette Paradigm 43"; Silhouette Paradigm 23"; Silhouette Paradigm 13mm, 23"; Silhouette Paradigm 13mm, 43"; Silhouette Paradigm 13mm, 32"; Silhouette Paradigm 32" || The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin
Manufacturer
Unomedical As
1 Event
Recall of Device Recall Paradigm Silouette Infusion SetThe Silouette Infusion Set
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Manufacturer
Unomedical As
Manufacturer Address
Unomedical As, Aholmvej 1 3 Osted, Roskilde Denmark
Manufacturer Parent Company (2017)
Triona Holding Sa
Source
USFDA
Language
English
Français
Español
한국어