Z-0359-2017 Class II Terminated

Recalled by Unomedical As — Roskilde

FDA device recall Z-0359-2017 was initiated by Unomedical As on Nov 7, 2014 and is designated Class II. Reason for recall: Tubing detachment The recall status is terminated (terminated Nov 16, 2016). Affected quantity: 9,782,880 units.

Recall details

Product Type
Devices
Report Date
Nov 9, 2016
Initiation Date
Nov 7, 2014
Termination Date
Nov 16, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
9,782,880 units

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

Reason for recall

Tubing detachment

Distribution pattern

Worldwide Distribution - US including CA, IN, PA, and Internationally to Canada, Korea, and Japan.

Code information

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,

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-0359-2017
openFDA file date
Nov 10, 2026
Loaded by RegDataLab
Nov 11, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

Source: openFDA record for Z-0359-2017. Report a data issue: hello@regdatalab.com.