Device Recall Paradigm Silouette Infusion SetThe Silouette Infusion Set

  • Modelo / 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,
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US including CA, IN, PA, and Internationally to Canada, Korea, and Japan.
  • Descripción del producto
    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

Fabricante

  • Dirección del fabricante
    Unomedical As, Aholmvej 1 3 Osted, Roskilde Denmark
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA