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
  • 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
  • 1 Event

Manufacturer

  • Manufacturer Address
    Unomedical As, Aholmvej 1 3 Osted, Roskilde Denmark
  • Manufacturer Parent Company (2017)
  • Source
    USFDA