CLASS II Device recall · Reported 1 Jul 2015 · FDA Enforcement Report

Sure T, contact, contact detach, neria, neria detach recalled

Unomedical As is recalling Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in, distributed in California, Illinois, Minnesota, Pennsylvania. The recall was initiated on 21 May 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes210131, 212482, 213575, 213576, 214509, 214511, 216175, 216295, 216296, 218110, 218111, 218685, 219030, 219075, 220160, 220161, 220163, 223771, 224282, 224283, 224284, 224285, 224286, 226935, 226939, 226940, 227062, 227063, 227064, 227065, 227892, 227894, 229302, 230245, 231124, 231127, 231130, 232701, 232702, 233875, 656782, 656785, 657341, 657836, 657966, 667536, 669845, 4262911, 4263093, 4263094, 4263095, 4263098, 4263099, 4263100, 4263112, 4263113, 4263130, 4263131, 4263132, 4263170, 4263171, 4263172, 4263178, 4263179, 4263293, 4263240, 4263241, 4263307, 4263308, 4263328, 4263329, 4263372, 4263391, 4263393, 4263394, 4263400, 4263420, 4263421, 4263458, 4263474, 4263475, 4263476, 4263486, 4263517, 4263529, 4263551, 4263552, 4263571, 4263572, 4263580, 4263609, 4263624, 4263631, 4263665, 4263677, 4263678, 4263694, 4263695, 4263696, 4263716, 4263718, 4263719, 4263738, 4263750, 4263778, 5000119, 5000120, 5001718, 5003702, 5003920, 5003921, 5006040, 5006041, 5006567, 5006568, 5006571, 5007991, 5008524, 5008525, 5008526, 5009947, 5009948, 5012473, 5013531, 5013532, 5015053, 5015054, 5015057, 5015102, 5015103, 5015176, 5015177, 5018162, 5018230, 5018233, 5018234, 5020390, 5020462, 5020466, 5020536, 5021240, 5021244, 5021308, 5021312, 5021570, 5022266, 5022267, 5022268, 5025138, 5025139, 5024140, 5025141, 5026432, 5026515, 5029022, 5029023, 5029136, 5029137, 5029146, 5029147, 5031807, 5031810, 5031874, 5031875, 5031883, 5031887, 5031900, 5031917, 5031924, 5031925, 5031926, 5031927, 5031928, 5031929, 5031930, 5031931, 5031932, 5024059, 5034061, 5034231, 5034232, 5034325, 5035097, 5036348, 5038182, 5038183, 5038184, 5038185, 5038186, 5038187, 5038188, 5040990, 5040991, 5040992, 5041073, 5041074, 5045147, 5045148, 5047241, 5047242, 5047243, 5047245, 5048097, 5053689, 5054465, 5054466, 5054550, 5054553, 5054554, 5057103, 5057104, 5057105, 5057106, 5058633, 5058637, 5058731, 5058732, 5058733, 5058734, 5062769, 5062770, 5062811, 5062812, 5062813, 5066512, 212859, 222980, 225533, 225534, 657344, 657344, 657345, 657346, 657683, 657684, 658194, 668655, 668656, 668657, 668660, 4262880, 4263000, 4263282, 4263326, 4263789, 4263789, 5008719, 5008720, 5009167, 5009168, 5009170, 5009172, 5017661, 5020515, 5020517, 5020518, 5024525, 5024530, 5028919, 5028935, 5036178, 5036179, 5046401, 5058738, 5060648, 5062986, 5063788, 210132, 210133, 210134, 210135, 210136, 211190, 211191, 211192, 211193, 211194, 212404, 212408, 212409, 212410, 212421, 212422, 212423, 212487, 212488, 212489, 212957, 213353, 213354, 213355, 213356, 213357, 215480, 215484, 215721, 215722, 215723, 215724, 215921, 215956, 215957, 215958, 215959, 215960, 215961, 215962, 216176, 216177, 216178, 216179, 216180, 216776, 216777, 216778, 216779, 216780, 218078, 218079, 218080, 218081, 218082, 218083, 218084, 218085, 218086, 218087, 218088, 218089, 218671, 218672, 218673, 218674, 218675, 218676, 218677, 218678, 219851, 219852, 219853, 219854, 219855, 219857, 219860, 219892, 220111, 220485, 220486, 220529, 220530, 220534, 220664, 220665, 220666, 220667, 220668, 220669, 220670, 220671, 220672, 220673, 220674, 220675, 220676, 220677, 220678, 220679, 220680, 220681, 220682, 220683, 221883, 223620, 223621, 223862, 223864, 223869, 223874, 223876, 223881, 223888, 223889, 223890, 223973, 223974, 223975, 224287, 224288, 224289, 224290, 224291, 224292, 224293, 224294, 224295, 224599, 224604, 224621, 224622, 224811, 224812, 224813, 224814, 225554, 225555, 225556, 225557, 225558, 225559, 225560, 226026, 226027, 226028, 226029, 226030, 226031, 226870, 226871, 226872, 227746, 227747, 227748, 227749, 228088, 228089, 228090, 228091, 228092, 228093, 229307, 229308, 229309, 229310, 229311, 229530, 229531, 229532, 229533, 229534, 220535, 220536, 230162, 230268, 230269, 230270, 230271, 230272, 230406, 230503, 230504, 231155, 231156, 231157, 231158, 231159, 231160, 231161, 232703, 232704, 232705, 232706, 234148, 234149, 234154, 234155, 234156, 234171, 234172, 234173, 234174, 234183, 234188, 234193, 234198, 234337, 234338, 234339, 234340, 234341, 234342, 234439, 656410, 656416, 656417, 656418, 656471, 656481, 656897, 656898, 656899, 656900, 656901, 656902, 656903, 656904, 656905, 656906, 656907, 657424, 657949, 657950, 657951, 657952, 657953, 657954, 657956, 657957, 657958, 657959, 657960, 666123, 666124, 667471, 667472, 667473, 667474, 667475, 667476, 667954, 667955, 667956, 668186, 668187, 668188, 668189, 668190, 668191, 668192, 668193, 668194, 668195, 668196, 668197, 668198, 669526, 669527, 669528, 669529, 669530, 669531, 669847, 4262872, 4262904, 4262910, 4262912, 4262913, 4262914, 4262915, 4262916, 4262917, 4262918, 4262919, 4262920, 4262926, 4262927, 4262928, 4262929, 4262930, 4262931, 4262932, 4262933, 4262940, 4262941, 4262942, 4262943, 4262955, 4262970, 4262971, 4262972, 4262973, 4262974, 4262975, 4262976, 4262977, 4262978, 4262979, 4262980, 4262981, 4262982, 4262983, 4262984, 4262985, 4262986, 4262992, 4262993, 4262994, 4262995, 4262996, 4262997, 4262998, 4263007, 4263008, 4263009, 4263010, 4263011, 4263012, 4263013, 4263014, 4263015, 4263016, 4263018, 4263019, 4263020, 4263021, 4263022, 4263040, 4263041, 4263042, 4263043, 4263044, 4263045, 4263050, 4263051, 4263052, 4263053, 4263054, 4263055, 4263056, 4263057, 4263058, 4263059, 4263060, 4263061, 4263062, 4263063, 4263075, 4263076, 4263077, 4263078, 4263079, 4263080, 4263081, 4263082, 4263083, 4263084, 4263085, 4263086, 4263096, 4263097, 4263101, 4263102, 4263103, 4263104, 4263105, 4263106, 4263107, 4263108, 4263109, 4263110, 4263111, 4263122, 4263123, 4263124, 4263125, 4263126, 4263127, 4263128, 4263129, 4263139, 4263140, 4263141, 4263142, 4263143, 4263144, 4263164, 4263165, 4263166, 4263167, 4263168, 4263169, 4263173, 4263176, 4263177, 4263184, 4263185, 4263186, 4263187, 4263188, 4263189, 4263194, 4263198, 4263199, 4263200, 4263201, 4263202, 4263217, 4263218, 4263219, 4263220, 4263221, 4263222, 4263223, 4263224, 4263225, 4263226, 4263227, 4263242, 4263243, 4263244, 4263245, 4263246, 4263247, 4263248, 4263249, 4263250, 4263251, 4263252, 4263253, 4263256, 4263257, 4263258, 4263259, 4263260, 4263261, 4263262, 4263270, 4263271, 4263272, 4263273, 4263274, 4263275, 4263290, 4263291, 4263292, 4263293, 4263294, 4263315, 4263316, 4263317, 4263318, 4263319, 4263320, 4263339, 4263340, 4263341, 4263342, 4263343, 4263344, 4263345, 4263346, 4263347, 4263365, 4263366, 4293367, 4263368, 4263369, 4263370, 4263371, 4263373, 4263374, 4263375, 4263376, 4263377, 4263378, 4263379, 4263380, 4263381, 4263382, 4263383, 4263392, 4263395, 4263396, 4263397, 4263398, 4263399, 4263413, 4263414, 4263415, 4263416, 4263417, 4263418, 4263426, 4263427, 4263428, 4263429, 4263430, 4263431, 4263432, 4263446, 4263447, 4263448, 4263449, 4263459, 4263460, 4263461, 4263462, 4263463, 4263469, 4263470, 4263471, 4263473, 4263477, 4263478, 4263479, 4263487, 4263488, 4263489, 4263490, 4263491, 4263496, 4263497, 4263498, 4263499, 4263500, 4263519, 4263520, 4263521, 4263522, 4263523, 4263527, 4263528, 4263530, 4263532, 4263533, 4263534, 4263546, 4263547, 4263548, 4263549, 4263550, 4263554, 4263555, 4263556, 4263566, 4263567, 4263568, 4263569, 4263570, 4263573, 4263574, 4263575, 4263576, 4263577, 4263581, 4263582, 4263583, 4263584, 4263585, 4263586, 4263603, 4263604, 4263605, 4263606, 4263607, 4263608, 4263613, 4263614, 4263615, 4263616, 4263617, 4263618, 4263619, 4263620, 4263621, 4263622, 4263623, 4263625, 4263626, 4263627, 4263628, 4263629, 4263630, 4263634, 4263635, 4263636, 4263637, 4263638, 4263639, 4263640, 4263647, 4263648, 4263649, 4263650, 4263651, 4263679, 4263680, 4263681, 4263682, 4263683, 4263691, 4263692, 4263693, 4263697, 4263698, 4263699, 4263700, 4263701, 4263702, 4263708, 4263709, 4263710, 4263711, 4263712, 4263713, 4263714, 4263715, 4263717, 4263720, 4263721, 4263722, 4263723, 4263724, 4263727, 4263728, 4263729, 4263730, 4263731, 4263732, 4263733, 4263734, 4263735, 4263736, 4263737, 4263743, 4263744, 4263745, 4263746, 4263747, 4263748, 4263749, 4253756, 4263757, 4263787, 5000126, 5000127, 5000128, 5000129, 5000130, 5000131, 5000132, 5000133, 5000134, 5000135, 5000136, 5000137, 5001295, 5001296, 5001297, 5001298, 5001299, 5001300, 5001301, 5001719, 5001720, 5001721, 5001722, 5001723, 5001724, 5001725, 5002089, 5002090, 5002091, 5002092, 5002093, 5002094, 5002095, 5002096, 5002775, 5002776, 5002778, 5002783, 5002811, 5002812, 5002813, 5002814, 5002815, 5002816, 5002817, 5002818, 5003831, 5003836, 5003837, 5003838, 5003839, 5003841, 5003922, 5003923, 5003924, 5003925, 5003926, 5003927, 5003928, 5003929, 5003930, 5003931, 5003932, 5003933, 5003934, 5003935, 5003936, 5003937, 5003938, 5004572, 5006881, 5007159, 5007162, 5007308, 5007309, 5007427, 5007428, 5007429, 5007430, 5007434, 5007450, 5007458, 5007464, 5007465, 5007467, 5008527, 5008528, 5008529, 5008530, 5008531, 5008532, 5009110, 5009111, 5009112, 5009113, 5009114, 5009115, 5009116, 5009949, 5009950, 5009951, 5009952, 5009953, 5010193, 5010202, 5010204, 5010207, 5010208, 5010863, 5010864, 5010865, 5010866, 5010867, 5010868, 5011144, 5011145, 5011146, 5011147, 5011148, 5011149, 5011150, 5011151, 5011152, 5011153, 5011835, 5011836, 5011837, 5011838, 5013133, 5013134, 5013807, 5013808, 5013809, 5013810, 3015152, 5015153, 5015154, 5015155, 5015156, 5016592, 5016595, 5016922, 5016923, 5016924, 5016925, 5016926, 5017077, 5017079, 5017081, 5017083, 5017085, 5017112, 5017113, 5017114, 5017115, 5017116, 5017117, 5017118, 5017119, 5017464, 5017466, 5017467, 5017629, 5017632, 5017636, 5017642, 5017653, 5017731, 5017732, 5017733, 5017734, 5017735, 5017736, 5019180, 5019182, 5019183, 5019185, 5019459, 5019460, 5019461, 5020537, 5020538, 5020539. 5020540, 5020541, 5020542, 5020543, 5020544, 5025445, 5025446, 5021555, 5021556, 5021557, 5021558, 5022230, 5022231, 5022232, 5022233, 5022954, 5022955, 5022956, 5022957, 5022958, 5023461, 5023462, 5023463, 5023464, 5023465, 5023466, 5023467, 5023468, 5023469, 5023470, 5024494, 5024495, 5024496, 5026739, 5026740, 5026741, 5026882, 5026883, 5028244, 5028245, 5028246, 5028251, 5028252, 5028253, 5028254, 5028255, 5028964, 5028965, 5028966, 5029016, 5029017, 5029018, 5029019, 5029020, 5029021, 5029024, 5029025, 5030892, 5030893, 5030894, 5030895, 5030896, 5030897, 5030898, 5030899, 5030903, 5030905, 5030906, 5030907, 5030942, 5030943, 5030944, 5030945, 5031933, 5031934, 5031935, 5032624, 5032625, 5032626, 5032627, 5032636, 5032640, 5032642, 5032644, 5032646, 5032648, 5032650, 5032652, 5032654, 5032816, 5032817, 5032818, 5032819, 5032820, 5033287, 5033393, 5033394, 5033395, 5033396, 5033397, 5033398, 5033399, 5033400, 5033401, 5033402, 5034244, 5034245, 5034326, 5034327, 5034328, 5034329, 5034330, 5034331, 5035649, 5035690, 5036354, 5036355, 5036356, 5036357, 5036358, 5038778, 5038779, 5038780, 5038781, 5038783, 5038785, 5038787, 5039578, 5039579, 5039580, 5039581, 5039582, 5039586, 5039589, 5039878, 5039879, 5039880, 5040157, 5040158, 5040159, 5040160, 5040464, 5040465, 5040466, 5040467, 5040468, 5040469, 5040470, 5040471, 5040472, 5040473, 5040474, 5041195, 5041196, 5042578, 5042580, 5042581, 5042582, 5042584, 5043094, 5043095, 5043100, 5043106, 5043112, 5043114, 5043117, 5043121, 5043122, 5043124, 5043329, 5043387, 5043414, 5043415, 5043417, 5043418, 5043419, 5043420, 5043421, 5043422, 5043423, 5043425, 5043426, 5043427, 5043428, 5043429, 5044841, 5044843, 5046393, 5046394, 5046395, 5046396, 5046397, 5046638, 5049939, 5046640, 5046641, 5046644, 5046645, 5047168, 5047170, 5047171, 5047172, 5047175, 5047177, 5047179, 5047510, 5047511, 5047580, 5047581, 5047582, 5047583, 5047584, 5049122, 5049123, 5049124, 5049125, 5050034, 5050035, 5050036, 5050037, 5050038, 5051560, 5051561, 5051562, 5051563, 5051564, 5052903, 5052904, 5052905, 5052906, 5052907, 5052908, 5053658, 5053661, 5053786, 5053787, 5053788, 5053789, 5053790, 5054558, 5054559, 5055463, 5055465, 5055496, 5055497, 5055498, 5056680, 5056681, 5056682, 5056683, 5056684, 5057047, 5057215, 5057217, 5057219, 5057221, 5057226, 5057231, 5057232, 5057241, 5057242, 5057243, 5057244, 5057245, 5057250, 5057251, 5057953, 5057954, 5057955, 5058702, 5058704, 5058706, 5059551, 5059552, 5059553, 5060205, 5060206, 5060207, 5060208, 5060209, 5060210, 5060946, 5060947, 5060948, 5060949, 5060950, 5060951, 5060952, 5060953, 5060988, 5060989, 5060990, 5060991, 5061496, 5061497, 5063694, 5063695, 5063696, 5063697, 5064141, 5064142, 5064143, 5064144, 5064145, 5064146, 5064299, 5064402, 5064403, 5064404, 5065089, 5065090, 5065106, 5066445, 5066513, 5066514, 5066515, 5066516, 5067182, 5067183, 5067184, 5067185, 5067587, 5068513, 5068524, 4262899, 4262905,4263025, 4263064, 4263065, 4263147, 4263207, 4263298, 4263299, 4263300, 4263444, 4263446, 4263501, 4263502, 4263503, and 4263504.

Quantity recalled22,976,870 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1821-2015
FDA event ID: 71332
Recalling firm: Unomedical As, Roskilde
Classification: Class II
Status: Terminated
Recall initiated: 21 May 2015
FDA classified: 19 Jun 2015
Reported: 1 Jul 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Infusion Pumps

Timeline

21 May 2015	Recall initiated by company
19 Jun 2015	Classified by FDA	+29 days
1 Jul 2015	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Unomedical has found that in rare cases the steel needle can break during use, interrupting the delivery of medication including insulin.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.

Where it was distributed

Worldwide Distribution -- US, including the states of CA, IL, MN, and PA; and, the countries of Australia, Bahrain, Belgium, Canada, China, Cypress, Denmark, Estonia, France, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Kuwait, Lebanon, Malaysia, Maldives, Oman, Schweiz, South Africa, Spain, Sweden, Switzerland, Netherlands, Turkey, United Arab Emirates, and United Kingdom.

California Illinois Minnesota Pennsylvania

Questions about this recall

Is Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in recalled?

Yes. Unomedical As recalled Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in on 21 May 2015. The recall is Class II and its status is Terminated. Recall number Z-1821-2015.

Why was it recalled?

Unomedical has found that in rare cases the steel needle can break during use, interrupting the delivery of medication including insulin.

Which lots are affected?

210131, 212482, 213575, 213576, 214509, 214511, 216175, 216295, 216296, 218110, 218111, 218685, 219030, 219075, 220160, 220161, 220163, 223771, 224282, 224283, 224284, 224285, 224286, 226935, 226939, 226940, 227062, 227063, 227064, 227065, 227892, 227894, 229302, 230245, 231124, 231127, 231130, 232701, 232702, 233875, 656782, 656785, 657341, 657836, 657966, 667536, 669845, 4262911, 4263093, 4263094, 4263095, 4263098, 4263099, 4263100, 4263112, 4263113, 4263130, 4263131, 4263132, 4263170, 4263171, 4263172, 4263178, 4263179, 4263293, 4263240, 4263241, 4263307, 4263308, 4263328, 4263329, 4263372, 4263391, 4263393, 4263394, 4263400, 4263420, 4263421, 4263458, 4263474, 4263475, 4263476, 4263486, 4263517, 4263529, 4263551, 4263552, 4263571, 4263572, 4263580, 4263609, 4263624, 4263631, 4263665, 4263677, 4263678, 4263694, 4263695, 4263696, 4263716, 4263718, 4263719, 4263738, 4263750, 4263778, 5000119, 5000120, 5001718, 5003702, 5003920, 5003921, 5006040, 5006041, 5006567, 5006568, 5006571, 5007991, 5008524, 5008525, 5008526, 5009947, 5009948, 5012473, 5013531, 5013532, 5015053, 5015054, 5015057, 5015102, 5015103, 5015176, 5015177, 5018162, 5018230, 5018233, 5018234, 5020390, 5020462, 5020466, 5020536, 5021240, 5021244, 5021308, 5021312, 5021570, 5022266, 5022267, 5022268, 5025138, 5025139, 5024140, 5025141, 5026432, 5026515, 5029022, 5029023, 5029136, 5029137, 5029146, 5029147, 5031807, 5031810, 5031874, 5031875, 5031883, 5031887, 5031900, 5031917, 5031924, 5031925, 5031926, 5031927, 5031928, 5031929, 5031930, 5031931, 5031932, 5024059, 5034061, 5034231, 5034232, 5034325, 5035097, 5036348, 5038182, 5038183, 5038184, 5038185, 5038186, 5038187, 5038188, 5040990, 5040991, 5040992, 5041073, 5041074, 5045147, 5045148, 5047241, 5047242, 5047243, 5047245, 5048097, 5053689, 5054465, 5054466, 5054550, 5054553, 5054554, 5057103, 5057104, 5057105, 5057106, 5058633, 5058637, 5058731, 5058732, 5058733, 5058734, 5062769, 5062770, 5062811, 5062812, 5062813, 5066512, 212859, 222980, 225533, 225534, 657344, 657344, 657345, 657346, 657683, 657684, 658194, 668655, 668656, 668657, 668660, 4262880, 4263000, 4263282, 4263326, 4263789, 4263789, 5008719, 5008720, 5009167, 5009168, 5009170, 5009172, 5017661, 5020515, 5020517, 5020518, 5024525, 5024530, 5028919, 5028935, 5036178, 5036179, 5046401, 5058738, 5060648, 5062986, 5063788, 210132, 210133, 210134, 210135, 210136, 211190, 211191, 211192, 211193, 211194, 212404, 212408, 212409, 212410, 212421, 212422, 212423, 212487, 212488, 212489, 212957, 213353, 213354, 213355, 213356, 213357, 215480, 215484, 215721, 215722, 215723, 215724, 215921, 215956, 215957, 215958, 215959, 215960, 215961, 215962, 216176, 216177, 216178, 216179, 216180, 216776, 216777, 216778, 216779, 216780, 218078, 218079, 218080, 218081, 218082, 218083, 218084, 218085, 218086, 218087, 218088, 218089, 218671, 218672, 218673, 218674, 218675, 218676, 218677, 218678, 219851, 219852, 219853, 219854, 219855, 219857, 219860, 219892, 220111, 220485, 220486, 220529, 220530, 220534, 220664, 220665, 220666, 220667, 220668, 220669, 220670, 220671, 220672, 220673, 220674, 220675, 220676, 220677, 220678, 220679, 220680, 220681, 220682, 220683, 221883, 223620, 223621, 223862, 223864, 223869, 223874, 223876, 223881, 223888, 223889, 223890, 223973, 223974, 223975, 224287, 224288, 224289, 224290, 224291, 224292, 224293, 224294, 224295, 224599, 224604, 224621, 224622, 224811, 224812, 224813, 224814, 225554, 225555, 225556, 225557, 225558, 225559, 225560, 226026, 226027, 226028, 226029, 226030, 226031, 226870, 226871, 226872, 227746, 227747, 227748, 227749, 228088, 228089, 228090, 228091, 228092, 228093, 229307, 229308, 229309, 229310, 229311, 229530, 229531, 229532, 229533, 229534, 220535, 220536, 230162, 230268, 230269, 230270, 230271, 230272, 230406, 230503, 230504, 231155, 231156, 231157, 231158, 231159, 231160, 231161, 232703, 232704, 232705, 232706, 234148, 234149, 234154, 234155, 234156, 234171, 234172, 234173, 234174, 234183, 234188, 234193, 234198, 234337, 234338, 234339, 234340, 234341, 234342, 234439, 656410, 656416, 656417, 656418, 656471, 656481, 656897, 656898, 656899, 656900, 656901, 656902, 656903, 656904, 656905, 656906, 656907, 657424, 657949, 657950, 657951, 657952, 657953, 657954, 657956, 657957, 657958, 657959, 657960, 666123, 666124, 667471, 667472, 667473, 667474, 667475, 667476, 667954, 667955, 667956, 668186, 668187, 668188, 668189, 668190, 668191, 668192, 668193, 668194, 668195, 668196, 668197, 668198, 669526, 669527, 669528, 669529, 669530, 669531, 669847, 4262872, 4262904, 4262910, 4262912, 4262913, 4262914, 4262915, 4262916, 4262917, 4262918, 4262919, 4262920, 4262926, 4262927, 4262928, 4262929, 4262930, 4262931, 4262932, 4262933, 4262940, 4262941, 4262942, 4262943, 4262955, 4262970, 4262971, 4262972, 4262973, 4262974, 4262975, 4262976, 4262977, 4262978, 4262979, 4262980, 4262981, 4262982, 4262983, 4262984, 4262985, 4262986, 4262992, 4262993, 4262994, 4262995, 4262996, 4262997, 4262998, 4263007, 4263008, 4263009, 4263010, 4263011, 4263012, 4263013, 4263014, 4263015, 4263016, 4263018, 4263019, 4263020, 4263021, 4263022, 4263040, 4263041, 4263042, 4263043, 4263044, 4263045, 4263050, 4263051, 4263052, 4263053, 4263054, 4263055, 4263056, 4263057, 4263058, 4263059, 4263060, 4263061, 4263062, 4263063, 4263075, 4263076, 4263077, 4263078, 4263079, 4263080, 4263081, 4263082, 4263083, 4263084, 4263085, 4263086, 4263096, 4263097, 4263101, 4263102, 4263103, 4263104, 4263105, 4263106, 4263107, 4263108, 4263109, 4263110, 4263111, 4263122, 4263123, 4263124, 4263125, 4263126, 4263127, 4263128, 4263129, 4263139, 4263140, 4263141, 4263142, 4263143, 4263144, 4263164, 4263165, 4263166, 4263167, 4263168, 4263169, 4263173, 4263176, 4263177, 4263184, 4263185, 4263186, 4263187, 4263188, 4263189, 4263194, 4263198, 4263199, 4263200, 4263201, 4263202, 4263217, 4263218, 4263219, 4263220, 4263221, 4263222, 4263223, 4263224, 4263225, 4263226, 4263227, 4263242, 4263243, 4263244, 4263245, 4263246, 4263247, 4263248, 4263249, 4263250, 4263251, 4263252, 4263253, 4263256, 4263257, 4263258, 4263259, 4263260, 4263261, 4263262, 4263270, 4263271, 4263272, 4263273, 4263274, 4263275, 4263290, 4263291, 4263292, 4263293, 4263294, 4263315, 4263316, 4263317, 4263318, 4263319, 4263320, 4263339, 4263340, 4263341, 4263342, 4263343, 4263344, 4263345, 4263346, 4263347, 4263365, 4263366, 4293367, 4263368, 4263369, 4263370, 4263371, 4263373, 4263374, 4263375, 4263376, 4263377, 4263378, 4263379, 4263380, 4263381, 4263382, 4263383, 4263392, 4263395, 4263396, 4263397, 4263398, 4263399, 4263413, 4263414, 4263415, 4263416, 4263417, 4263418, 4263426, 4263427, 4263428, 4263429, 4263430, 4263431, 4263432, 4263446, 4263447, 4263448, 4263449, 4263459, 4263460, 4263461, 4263462, 4263463, 4263469, 4263470, 4263471, 4263473, 4263477, 4263478, 4263479, 4263487, 4263488, 4263489, 4263490, 4263491, 4263496, 4263497, 4263498, 4263499, 4263500, 4263519, 4263520, 4263521, 4263522, 4263523, 4263527, 4263528, 4263530, 4263532, 4263533, 4263534, 4263546, 4263547, 4263548, 4263549, 4263550, 4263554, 4263555, 4263556, 4263566, 4263567, 4263568, 4263569, 4263570, 4263573, 4263574, 4263575, 4263576, 4263577, 4263581, 4263582, 4263583, 4263584, 4263585, 4263586, 4263603, 4263604, 4263605, 4263606, 4263607, 4263608, 4263613, 4263614, 4263615, 4263616, 4263617, 4263618, 4263619, 4263620, 4263621, 4263622, 4263623, 4263625, 4263626, 4263627, 4263628, 4263629, 4263630, 4263634, 4263635, 4263636, 4263637, 4263638, 4263639, 4263640, 4263647, 4263648, 4263649, 4263650, 4263651, 4263679, 4263680, 4263681, 4263682, 4263683, 4263691, 4263692, 4263693, 4263697, 4263698, 4263699, 4263700, 4263701, 4263702, 4263708, 4263709, 4263710, 4263711, 4263712, 4263713, 4263714, 4263715, 4263717, 4263720, 4263721, 4263722, 4263723, 4263724, 4263727, 4263728, 4263729, 4263730, 4263731, 4263732, 4263733, 4263734, 4263735, 4263736, 4263737, 4263743, 4263744, 4263745, 4263746, 4263747, 4263748, 4263749, 4253756, 4263757, 4263787, 5000126, 5000127, 5000128, 5000129, 5000130, 5000131, 5000132, 5000133, 5000134, 5000135, 5000136, 5000137, 5001295, 5001296, 5001297, 5001298, 5001299, 5001300, 5001301, 5001719, 5001720, 5001721, 5001722, 5001723, 5001724, 5001725, 5002089, 5002090, 5002091, 5002092, 5002093, 5002094, 5002095, 5002096, 5002775, 5002776, 5002778, 5002783, 5002811, 5002812, 5002813, 5002814, 5002815, 5002816, 5002817, 5002818, 5003831, 5003836, 5003837, 5003838, 5003839, 5003841, 5003922, 5003923, 5003924, 5003925, 5003926, 5003927, 5003928, 5003929, 5003930, 5003931, 5003932, 5003933, 5003934, 5003935, 5003936, 5003937, 5003938, 5004572, 5006881, 5007159, 5007162, 5007308, 5007309, 5007427, 5007428, 5007429, 5007430, 5007434, 5007450, 5007458, 5007464, 5007465, 5007467, 5008527, 5008528, 5008529, 5008530, 5008531, 5008532, 5009110, 5009111, 5009112, 5009113, 5009114, 5009115, 5009116, 5009949, 5009950, 5009951, 5009952, 5009953, 5010193, 5010202, 5010204, 5010207, 5010208, 5010863, 5010864, 5010865, 5010866, 5010867, 5010868, 5011144, 5011145, 5011146, 5011147, 5011148, 5011149, 5011150, 5011151, 5011152, 5011153, 5011835, 5011836, 5011837, 5011838, 5013133, 5013134, 5013807, 5013808, 5013809, 5013810, 3015152, 5015153, 5015154, 5015155, 5015156, 5016592, 5016595, 5016922, 5016923, 5016924, 5016925, 5016926, 5017077, 5017079, 5017081, 5017083, 5017085, 5017112, 5017113, 5017114, 5017115, 5017116, 5017117, 5017118, 5017119, 5017464, 5017466, 5017467, 5017629, 5017632, 5017636, 5017642, 5017653, 5017731, 5017732, 5017733, 5017734, 5017735, 5017736, 5019180, 5019182, 5019183, 5019185, 5019459, 5019460, 5019461, 5020537, 5020538, 5020539. 5020540, 5020541, 5020542, 5020543, 5020544, 5025445, 5025446, 5021555, 5021556, 5021557, 5021558, 5022230, 5022231, 5022232, 5022233, 5022954, 5022955, 5022956, 5022957, 5022958, 5023461, 5023462, 5023463, 5023464, 5023465, 5023466, 5023467, 5023468, 5023469, 5023470, 5024494, 5024495, 5024496, 5026739, 5026740, 5026741, 5026882, 5026883, 5028244, 5028245, 5028246, 5028251, 5028252, 5028253, 5028254, 5028255, 5028964, 5028965, 5028966, 5029016, 5029017, 5029018, 5029019, 5029020, 5029021, 5029024, 5029025, 5030892, 5030893, 5030894, 5030895, 5030896, 5030897, 5030898, 5030899, 5030903, 5030905, 5030906, 5030907, 5030942, 5030943, 5030944, 5030945, 5031933, 5031934, 5031935, 5032624, 5032625, 5032626, 5032627, 5032636, 5032640, 5032642, 5032644, 5032646, 5032648, 5032650, 5032652, 5032654, 5032816, 5032817, 5032818, 5032819, 5032820, 5033287, 5033393, 5033394, 5033395, 5033396, 5033397, 5033398, 5033399, 5033400, 5033401, 5033402, 5034244, 5034245, 5034326, 5034327, 5034328, 5034329, 5034330, 5034331, 5035649, 5035690, 5036354, 5036355, 5036356, 5036357, 5036358, 5038778, 5038779, 5038780, 5038781, 5038783, 5038785, 5038787, 5039578, 5039579, 5039580, 5039581, 5039582, 5039586, 5039589, 5039878, 5039879, 5039880, 5040157, 5040158, 5040159, 5040160, 5040464, 5040465, 5040466, 5040467, 5040468, 5040469, 5040470, 5040471, 5040472, 5040473, 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Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Unomedical As

All 7

Reported	Class	Recall	Company	Reason	Where
9 Nov 2016Device	CLASS II	Infusion Set, Comfort, 23" Hosp recalled by Unomedical As	Unomedical As	Other	Nationwide
9 Nov 2016Device	CLASS II	Silhouette Paradigm, 18"; Silhouette 43"; Silhouette 23" recalled	Unomedical As	Other	Nationwide
9 Nov 2016Device	CLASS II	SureT G29, 18", Paradigm recalled by Unomedical As	Unomedical As	Other	Nationwide
9 Nov 2016Device	CLASS II	Contact Detach, 23", G29 recalled by Unomedical As	Unomedical As	Other	Nationwide
9 Nov 2016Device	CLASS II	AC TenderLink 13/30 recalled by Unomedical As	Unomedical As	Other	Nationwide

Other Infusion Pumps recalls

All 546

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Baxter Novum IQ Syringe Pump, Loaner recalled by Baxter Healthcare	Baxter Healthcare	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Baxter Novum IQ Syringe Pump recalled by Baxter Healthcare	Baxter Healthcare	Device Malfunction	Nationwide
19 Aug 2026Device	CLASS I	Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product recalled	Baxter Healthcare	Other	Nationwide
22 Jul 2026Device	CLASS II	Plum Solo Precision IV Pump, v1.0.3 recalled by ICU Medical	ICU Medical	Other	Nationwide
1 Jul 2026Device	CLASS II	Intera Oncology Intera 3000 Hepatic Artery Infusion Pump recalled	Boston Scientific	Packaging Defects	Nationwide