Class 2 Device Recall Medfusion Model 3500 Syringe Pump

• Date Initiated by Firm: December 19, 2023
• Date Posted: April 15, 2024
• Recall Status: Open, Classified
• Recall Number: Z-1540-2024
• Recall Event ID: 93771
• 510(K)Number: K040899
• Product Classification: Pump, infusion - Product Code FRN
• Product: Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500
• Code Information: All serial numbers Medfusion Model 3500 pumps manufactured or serviced with these potentially affected Barrel Clamp Guides between Jul-2016 and Apr-2021. a) 3500, UDI/DI NONE, Serial Numbers: M02939, M03874, M09235, M09277, M09440, M09611, M09616, M10171, M10178, M10184, M10211, M10277, M10385, M10621, M11229, M12020, M12026, M12252, M12253, M12254, M13692, M14074, M14737, M15127, M15867, M15889, M16087, M16525, M17236, M17252, M18256, M18273, M18495, M18544, M18589, M18697, M18871, M19131, M21028, M21729, M21739, M22438, M24137, M24448, M28363, M28500, M28504, M30668, M30820, M32347, M36928, M39766; b) 3500-0600-00, UDI/DI 10610586041259, Serial Numbers: M107413, M107445, M107557, M107606, M107707, M107718, M110082, M110289, M110363, M111064, M73212, M-8833, M-8834, M-9284, M-9285, M-9286, M-9301, M-9302, M-9303; c) 3500-0600-01, UDI/DI 10610586041242, Serial Numbers: M100101, M102639, M102877, M103027, M103063, M103064, M103065, M103068, M103093, M103095, M103097, M103098, M103099, M103100, M103101, M103191, M103193, M103203, M103230, M103231, M103232, M103288, M103308, M103309, M103467, M103597, M103598, M103599, M103605, M103608, M103632, M103655, M103656, M103703, M103704, M103705, M103706, M103721, M103777, M103780, M103781, M103852, M103910, M103912, M103913, M103914, M103915, M103917, M103918, M103919, M103920, M103923, M103939, M103965, M103968, M104023, M104031, M104077, M104081, M104082, M104086, M104167, M104168, M104196, M104203, M104214, M104215, M104216, M104224, M104225, M104226, M104227, M104240, M104247, M104250, M104335, M104336, M104340, M104342, M104573, M104574, M104586, M105017, M105388, M105406, M105427, M105494, M105523, M105539, M105546, M105550, M105560, M105563, M105638, M105654, M105661, M105682, M105830, M105893, M105955, M106092, M106254, M106370, M106398, M106403, M106404, M106433, M106457, M106460, M106463, M106506, M106522, M106600, M106604, M106623, M106627, M106628, M106631, M106632, M106659, M106677, M106681, M106715, M106718, M106724, M106727, M106729, M106732, M106738, M106739, M106743, M106744, M106747, M106750, M106756, M106769, M106773, M106774, M106782, M106786, M106790, M106910, M106911, M106925, M106937, M106938, M106964, M106978, M106992, M106993, M106994, M106995, M106996, M106998, M107000, M107003, M107009, M107010, M107011, M107012, M107014, M107016, M107022, M107104, M107105, M107106, M107107, M107108, M107109, M107110, M107111, M107112, M107113, M107114, M107115, M107116, M107117, M107118, M107119, M107120, M107121, M107122, M107123, M107124, M107125, M107126, M107127, M107128, M107129, M107130, M107131, M107132, M107133, M107134, M107135, M107136, M107137, M107138, M107139, M107140, M107141, M107142, M107143, M107144, M107145, M107146, M107147, M107148, M107149, M107150, M107151, M107152, M107153, M107154, M107155, M107156, M107157, M107158, M107159, M107160, M107161, M107162, M107163, M107164, M107165, M107166, M107167, M107168, M107169, M107170, M107171, M107172, M107173, M107174, M107175, M107176, M107177, M107178, M107179, M107180, M107181, M107182, M107183, M107184, M107185, M107186, M107187, M107188, M107189, M107190, M107191, M107192, M107193, M107194, M107195, M107196, M107197, M107198, M107199, M107200, M107201, M107202, M107203, M107204, M107205, M107206, M107207, M107208, M107209, M107210, M107211, M107212, M107213, M107214, M107215, M107216, M107217, M107218, M107219, M107220, M107221, M107222, M107223, M107224, M107225, M107226, M107227, M107228, M107229, M107230, M107231, M107232, M107233, M107234, M107235, M107236, M107237, M107238, M107239, M107240, M107241, M107242, M107243, M107244, M107245, M107246, M107247, M107248, M107249, M107250, M107251, M107252, M107253, M107254, M107255, M107256, M107257, M107258, M107259, M107260, M107261, M107262, M107263, M107264, M107265, M107266, M107267, M107268, M107269, M107270, M107271, M107272, M107273, M107274, M107275, M107276, M107277, M107278, M107279, M107280, M107281, M107282, M107283, M107284, M107285, M107286, M107287, M107288, M107289, M107290, M107291, M107292, M107293, M107294, M107295, M107296, M107297, M107298, M107299, M107300, M107301, M107302, M107303, M107304, M107305, M107306, M107307, M107308, M107309, M107310, M107311, M107312, M107313, M107314, M107315, M107316, M107317, M107318, M107319, M107320, M107321, M107322, M107323, M107324, M107325, M107326, M107327, M107328, M107329, M107330, M107331, M107332, M107333, M107334, M107335, M107336, M107337, M107338, M107339, M107340, M107341, M107342, M107343, M107344, M107345, M107346, M107347, M107348, M107349, M107350, M107351, M107352, M107353, M107354, M107355, M107356, M107357, M107358, M107359, M107360, M107361, M107362, M107363, M107364, M107365, M107366, M107367, M107368, M107369, M107370, M107371, M107372, M107373, M107374, M107375, M107376, M107377, M107378, M107379, M107380, M107381, M107382, M107383, M107384, M107385, M107386, M107387, M107388, M107389, M107390, M107391, M107392, M107393, M107394, M107395, M107396, M107397, M107398, M107399, M107400, M107401, M107402, M107403, M107404, M107405, M107406, M107407, M107408, M107409, M107410, M107412, M107414, M107415, M107416, M107417, M107418, M107419, M107420, M107421, M107422, M107423, M107424, M107425, M107426, M107428, M107429, M107430, M107431, M107432, M107433, M107434, M107435, M107436, M107437, M107438, M107439, M107440, M107441, M107442, M107443, M107444, M107446, M107447, M107448, M107449, M107450, M107451, M107452, M107453, M107455, M107456, M107457, M107458, M107459, M107460, M107461, M107462, M107463, M107464, M107465, M107466, M107467, M107468, M107469, M107470, M107471, M107472, M107473, M107474, M107475, M107476, M107477, M107478, M107479, M107480, M107481, M107482, M107483, M107484, M107485, M107486, M107487, M107488, M107489, M107490, M107491, M107492, M107493, M107494, M107495, M107496, M107497, M107498, M107499, M107500, M107501, M107502, M107503, M107504, M107505, M107506, M107507, M107508, M107509, M107510, M107511, M107512, M107513, M107514, M107515, M107516, M107517, M107518, M107519, M107520, M107521, M107522, M107523, M107524, M107525, M107526, M107527, M107528, M107529, M107530, M107531, M107532, M107533, M107534, M107535, M107536, M107537, M107538, M107539, M107540, M107541, M107542, M107543, M107544, M107545, M107546, M107547, M107548, M107549, M107550, M107551, M107552, M107553, M107554, M107555, M107556, M107558, M107559, M107560, M107561, M107562, M107563, M107564, M107565, M107566, M107567, M107568, M107569, M107570, M107571, M107572, M107573, M107574, M107575, M107576, M107577, M107578, M107579, M107580, M107581, M107582, M107583, M107584, M107585, M107586, M107587, M107588, M107589, M107590, M107591, M107592, M107593, M107594, M107595, M107596, M107597, M107598, M107599, M107600, M107601, M107602, M107603, M107604, M107605, M107607, M107608, M107609, M107610, M107611, M107620, M107621, M107622, M107623, M107624, M107625, M107626, M107627, M107628, M107629, M107630, M107631, M107632, M107633, M107634, M107635, M107636, M107646, M107647, M107648, M107649, M107650, M107651, M107652, M107653, M107654, M107655, M107656, M107657, M107658, M107659, M107660, M107661, M107662, M107663, M107664, M107665, M107666, M107667, M107668, M107669, M107670, M107671, M107672, M107673, M107674, M107675, M107676, M107677, M107678, M107679, M107680, M107681, M107682, M107683, M107684, M107685, M107686, M107687, M107688, M107689, M107690, M107691, M107692, M107693, M107694, M107695, M107696, M107697, M107698, M107699, M107700, M107701, M107702, M107703, M107704, M107705, M107706, M107708, M107709, M107710, M107711, M107712, M107713, M107714, M107715, M107716, M107717, M107719, M107720, M107721, M107722, M107723, M107724, M107725, M107726, M107727, M107728, M107729, M107730, M107731, M107732, M107733, M107734, M107735, M107736, M107737, M107738, M107739, M107740, M107741, M107742, M107743, M107744, M107745, M107746, M107747, M107748, M107749, M107750, M107751, M107752, M107753, M107754, M107755, M107756, M107757, M107758, M107759, M107760, M107762, M107763, M107764, M107765, M107766, M107767, M107768, M107769, M107770, M107771, M107772, M107773, M107774, M107775, M107776, M107777, M107778, M107779, M107780, M107781, M107782, M107783, M107784, M107785, M107786, M107787, M107788, M107789, M107790, M107791, M107792, M107793, M107794, M107795, M107796, M107797, M107798, M107799, M107800, M107801, M107802, M107803, M107804, M107805, M107806, M107807, M107808, M107809, M107810, M107811, M107812, M107813, M107814, M107815, M107816, M107817, M107818, M107819, M107820, M107821, M107822, M107823, M107824, M107825, M107841, M107842, M107843, M107844, M107845, M107846, M107847, M107848, M107849, M107850, M107851, M107852, M107853, M107854, M107855, M107856, M107857, M107858, M107859, M107860, M107861, M107862, M107863, M107864, M107865, M107866, M107867, M107868, M107869, M107870, M107871, M107872, M107873, M107874, M107875, M107876, M107877, M107878, M107879, M107880, M107881, M107882, M107883, M107884, M107885, M107886, M107887, M107888, M107889, M107890, M107891, M107892, M107893, M107894, M107895, M107896, M107898, M107899, M107900, M107901, M107902, M107903, M107904, M107905, M107906, M107907, M107908, M107909, M107910, M107911, M107912, M107913, M107914, M107915, M107916, M107917, M107918, M107919, M107920, M107921, M107922, M107923, M107924, M107925, M107926, M107927, M107928, M107929, M107930, M107931, M107932, M107933, M107934, M107935, M107936, M107937, M107938, M107939, M107940, M107941, M107942, M107943, M107944, M107945, M107946, M107947, M107948, M107949, M107950, M107951, M107952, M107953, M107954, M107955, M107956, M107957, M107958, M107959, M107960, M107961, M107962, M107963, M107964, M107965, M107966, M107967, M107968, M107969, M107970, M107971, M107972, M107973, M107974, M107975, M107981, M107982, M107983, M107984, M107985, M107986, M107987, M107988, M107989, M107990, M107991, M107992, M107993, M107994, M107995, M107996, M107997, M107998, M107999, M108000, M108001, M108002, M108003, M108004, M108005, M108006, M108008, M108009, M108010, M108011, M108012, M108013, M108014, M108015, M108016, M108017, M108018, M108019, M108020, M108021, M108022, M108023, M108024, M108025, M108026, M108027, M108028, M108029, M108030, M108031, M108032, M108033, M108034, M108035, M108036, M108037, M108038, M108039, M108040, M108041, M108042, M108043, M108044, M108045, M108046, M108047, M108048, M108049, M108050, M108051, M108052, M108053, M108054, M108055, M108056, M108057, M108058, M108059, M108060, M108061, M108062, M108063, M108064, M108065, M108066, M108067, M108068, M108069, M108070, M108071, M108072, M108073, M108074, M108075, M108076, M108077, M108078, M108079, M108080, M108081, M108082, M108083, M108084, M108085, M108086, M108087, M108088, M108089, M108090, M108091, M108092, M108093, M108094, M108095, M108096, M108097, M108098, M108099, M108100, M108101, M108102, M108103, M108104, M108105, M108106, M108107, M108108, M108109, M108110, M108111, M108112, M108113, M108114, M108115, M108116, M108117, M108118, M108119, M108120, M108121, M108122, M108123, M108124, M108125, M108126, M108127, M108128, M108129, M108130, M108131, M108132, M108133, M108134, M108135, M108136, M108137, M108138, M108139, M108140, M108141, M108142, M108143, M108144, M108145, M108146, M108147, M108148, M108149, M108150, M108151, M108152, M108153, M108154, M108155, M108156, M108157, M108158, M108159, M108160, M108161, M108162, M108163, M108164, M108165, M108166, M108167, M108168, M108169, M108170, M108171, M108172, M108173, M108174, M108175, M108176, M108177, M108178, M108179, M108180, M108181, M108182, M108183, M108184, M108185, M108186, M108187, M108188, M108189, M108190, M108191, M108192, M108193, M108194, M108195, M108196, M108197, M108198, M108199, M108200, M108201, M108202, M108203, M108204, M108205, M108206, M108207, M108208, M108222, M108223, M108224, M108225, M108226, M108258, M108262, M108289, M108330, M108339, M108354, M108355, M108360, M108375, M108389, M108391, M108439, M108440, M108443, M108444, M108445, M108464, M108483, M108486, M108487, M108495, M108499, M108500, M108507, M108508, M108529, M108531, M108536, M108554, M108565, M108567, M108643, M108644, M108673, M108676, M108708, M108744, M108786, M108811, M108812, M108813, M108821, M108822, M108824, M108825, M108826, M108827, M108828, M108864, M108868, M108878, M108879, M108908, M108910, M108984, M108991, M109015, M109026, M109027, M109043, M109044, M109076, M109098, M109100, M109101, M109102, M109103, M109144, M109148, M109199, M109200, M109201, M109202, M109203, M109204, M109205, M109206, M109207, M109208, M109209, M109210, M109211, M109212, M109213, M109214, M109215, M109216, M109217, M109218, M109219, M109220, M109221, M109222, M109223, M109224, M109225, M109226, M109227, M109228, M109229, M109230, M109231, M109232, M109233, M109234, M109235, M109236, M109237, M109238, M109239, M109240, M109241, M109242, M109243, M109244, M109245, M109246, M109247, M109248, M109249, M109250, M109251, M109252, M109253, M109254, M109255, M109256, M109257, M109258, M109259, M109260, M109261, M109262, M109263, M109264, M109265, M109266, M109267, M109268, M109269, M109270, M109271, M109272, M109273, M109274, M109275, M109276, M109277, M109278, M109279, M109280, M109281, M109282, M109283, M109284, M109285, M109286, M109287, M109288, M109289, M109290, M109291, M109292, M109293, M109294, M109295, M109296, M109297, M109298, M109299, M109300, M109301, M109302, M109303, M109304, M109305, M109306, M109307, M109308, M109309, M109310, M109311, M109312, M109313, M109314, M109315, M109316, M109318, M109319, M109320, M109321, M109322, M109323, M109324, M109325, M109326, M109327, M109328, M109329, M109330, M109331, M109332, M109333, M109334, M109335, M109336, M109337, M109338, M109339, M109340, M109341, M109342, M109343, M109344, M109345, M109346, M109347, M109348, M109349, M109350, M109351, M109352, M109353, M109354, M109355, M109356, M109357, M109358, M109359, M109360, M109361, M109362, M109363, M109364, M109365, M109366, M109367, M109368, M109369, M109370, M109371, M109372, M109373, M109374, M109375, M109376, M109377, M109378, M109379, M109380, M109381, M109382, M109383, M109384, M109385, M109386, M109387, M109388, M109389, M109390, M109391, M109392, M109393, M109394, M109395, M109396, M109397, M109398, M109399, M109400, M109401, M109402, M109403, M109404, M109405, M109406, M109407, M109408, M109409, M109410, M109411, M109412, M109413, M109414, M109415, M109416, M109417, M109418, M109419, M109420, M109421, M109422, M109423, M109424, M109425, M109426, M109427, M109428, M109429, M109430, M109432, M109433, M109434, M109435, M109436, M109437, M109438, M109439, M109440, M109441, M109442, M109443, M109444, M109445, M109446, M109447, M109448, M109449, M109450, M109451, M109452, M109453, M109454, M109455, M109456, M109457, M109458, M109459, M109460, M109461, M109462, M109463, M109464, M109465, M109466, M109467, M109468, M109469, M109470, M109471, M109472, M109473, M109474, M109475, M109476, M109477, M109478, M109479, M109480, M109481, M109482, M109483, M109484, M109485, M109486, M109487, M109488, M109489, M109490, M109491, M109492, M109493, M109494, M109495, M109496, M109497, M109498, M109499, M109500, M109501, M109502, M109503, M109504, M109505, M109506, M109507, M109508, M109509, M109510, M109511, M109512, M109513, M109514, M109515, M109516, M109517, M109518, M109519, M109520, M109521, M109522, M109523, M109524, M109525, M109526, M109527, M109528, M109529, M109530, M109531, M109532, M109533, M109534, M109535, M109536, M109537, M109538, M109539, M109540, M109541, M109542, M109543, M109544, M109545, M109546, M109547, M109548, M109549, M109550, M109551, M109552, M109553, M109554, M109555, M109556, M109557, M109558, M109559, M109560, M109561, M109562, M109563, M109564, M109565, M109566, M109567, M109568, M109569, M109570, M109571, M109572, M109573, M109574, M109575, M109576, M109577, M109578, M109579, M109580, M109581, M109582, M109583, M109584, M109585, M109586, M109587, M109588, M109589, M109590, M109591, M109592, M109593, M109594, M109595, M109596, M109597, M109598, M109599, M109600, M109601, M109602, M109603, M109604, M109605, M109606, M109607, M109608, M109609, M109610, M109611, M109612, M109613, M109614, M109615, M109616, M109617, M109618, M109619, M109620, M109621, M109622, M109623, M109624, M109625, M109626, M109627, M109628, M109629, M109630, M109631, M109632, M109633, M109634, M109635, M109636, M109637, M109638, M109639, M109640, M109641, M109642, M109643, M109644, M109645, M109646, M109647, M109648, M109649, M109650, M109651, M109652, M109653, M109654, M109655, M109656, M109657, M109658, M109659, M109660, M109661, M109662, M109663, M109664, M109665, M109666, M109667, M109668, M109669, M109670, M109671, M109672, M109673, M109674, M109675, M109676, M109677, M109678, M109679, M109680, M109681, M109682, M109683, M109684, M109685, M109686, M109687, M109688, M109689, M109690, M109691, M109692, M109693, M109694, M109695, M109696, M109697, M109698, M109699, M109700, M109701, M109702, M109703, M109704, M109705, M109706, M109707, M109708, M109709, M109710, M109711, M109712, M109713, M109714, M109715, M109716, M109717, M109718, M109719, M109720, M109721, M109722, M109723, M109724, M109725, M109726, M109727, M109728, M109729, M109730, M109731, M109732, M109733, M109734, M109735, M109736, M109737, M109738, M109739, M109740, M109741, M109742, M109743, M109744, M109745, M109746, M109747, M109748, M109749, M109750, M109751, M109752, M109753, M109754, M109755, M109756, M109757, M109758, M109759, M109760, M109761, M109762, M109763, M109764, M109765, M109766, M109767, M109768, M109769, M109770, M109771, M109772, M109773, M109774, M109775, M109776, M109777, M109778, M109779, M109780, M109781, M109782, M109783, M109784, M109785, M109786, M109787, M109788, M109789, M109790, M109804, M109805, M109806, M109807, M109808, M109809, M109810, M109811, M109812, M109813, M109814, M109815, M109816, M109817, M109818, M109819, M109820, M109821, M109822, M109823, M109824, M109825, M109826, M109827, M109828, M109829, M109830, M109831, M109832, M109833, M109834, M109835, M109836, M109837, M109838, M109839, M109840, M109841, M109842, M109843, M109844, M109845, M109846, M109847, M109848, M109849, M109850, M109851, M109852, M109853, M109854, M109855, M109856, M109857, M109858, M109859, M109860, M109861, M109862, M109863, M109864, M109865, M109866, M109867, M109868, M109869, M109870, M109871, M109872, M109873, M109874, M109875, M109876, M109877, M109878, M109879, M109880, M109881, M109882, M109883, M109884, M109885, M109886, M109887, M109888, M109889, M109890, M109891, M109892, M109893, M109895, M109896, M109897, M109898, M109899, M109900, M109901, M109902, M109903, M109904, M109905, M109906, M109907, M109908, M109909, M109910, M109911, M109912, M109913, M109914, M109915, M109916, M109917, M109918, M109919, M109920, M109921, M109922, M109923, M109924, M109925, M109926, M109927, M109928, M109929, M109930, M109931, M109932, M109933, M109934, M109935, M109936, M109937, M109938, M109939, M109940, M109941, M109942, M109943, M109944, M109945, M109946, M109947, M109948, M109949, M109950, M109951, M109952, M109953, M109954, M109955, M109956, M109957, M109958, M109959, M109960, M109961, M109962, M109963, M109964, M109965, M109966, M109967, M109968, M109969, M109970, M109971, M109972, M109973, M109974, M109975, M109976, M109977, M109978, M109979, M109980, M109981, M109982, M109983, M109984, M109994, M109995, M109996, M109997, M109998, M109999, M110000, M110001, M110002, M110003, M110004, M110005, M110006, M110007, M110008, M110009, M110010, M110011, M110012, M110013, M110014, M110015, M110016, M110017, M110018, M110019, M110020, M110021, M110022, M110023, M110024, M110025, M110026, M110027, M110028, M110029, M110030, M110031, M110032, M110033, M110034, M110035, M110036, M110037, M110038, M110039, M110040, M110041, M110042, M110043, M110044, M110045, M110046, M110047, M110048, M110049, M110050, M110051, M110052, M110053, M110054, M110055, M110056, M110057, M110058, M110059, M110060, M110061, M110062, M110063, M110064, M110065, M110066, M110067, M110068, M110069, M110070, M110071, M110072, M110073, M110074, M110075, M110076, M110077, M110078, M110079, M110080, M110081, M110083, M110088, M110089, M110090, M110091, M110092, M110093, M110094, M110095, M110096, M110097, M110098, M110099, M110100, M110101, M110102, M110103, M110104, M110105, M110106, M110107, M110108, M110109, M110110, M110111, M110112, M110113, M110114, M110115, M110116, M110117, M110118, M110119, M110120, M110121, M110122, M110123, M110124, M110125, M110126, M110127, M110128, M110129, M110130, M110131, M110132, M110133, M110134, M110135, M110136, M110137, M110138, M110139, M110140, M110141, M110142, M110143, M110144, M110145, M110146, M110147, M110148, M110149, M110150, M110151, M110152, M110153, M110154, M110155, M110156, M110157, M110158, M110159, M110160, M110161, M110162, M110163, M110164, M110165, M110166, M110167, M110168, M110169, M110170, M110171, M110172, M110173, M110174, M110175, M110176, M110177, M110178, M110179, M110180, M110181, M110182, M110183, M110184, M110185, M110186, M110187, M110188, M110189, M110190, M110191, M110192, M110193, M110194, M110195, M110196, M110197, M110198, M110199, M110200, M110201, M110202, M110203, M110204, M110205, M110206, M110207, M110208, M110209, M110210, M110211, M110212, M110213, M110214, M110215, M110216, M110217, M110218, M110219, M110220, M110221, M110222, M110237, M110238, M110239, M110240, M110241, M110242, M110243, M110244, M110245, M110246, M110247, M110248, M110249, M110250, M110251, M110252, M110253, M110254, M110255, M110256, M110257, M110258, M110259, M110260, M110261, M110262, M110263, M110264, M110265, M110266, M110267, M110268, M110269, M110270, M110271, M110272, M110273, M110274, M110275, M110276, M110277, M110278, M110279, M110280, M110281, M110284, M110285, M110286, M110287, M110288, M110290, M110291, M110292, M110293, M110294, M110295, M110296, M110297, M110298, M110299, M110300, M110301, M110302, M110303, M110304, M110305, M110306, M110307, M110308, M110309, M110310, M110311, M110312, M110313, M110314, M110315, M110316, M110317, M110318, M110319, M110320, M110321, M110322, M110323, M110324, M110325, M110326, M110327, M110328, M110329, M110330, M110331, M110332, M110333, M110334, M110335, M110336, M110337, M110338, M110339, M110340, M110341, M110342, M110343, M110344, M110345, M110346, M110347, M110348, M110349, M110350, M110351, M110352, M110353, M110354, M110355, M110356, M110357, M110358, M110359, M110360, M110361, M110362, M110364, M110365, M110366, M110367, M110368, M110369, M110370, M110371, M110372, M110373, M110388, M110389, M110390, M110391, M110392, M110393, M110394, M110395, M110396, M110397, M110398, M110399, M110400, M110401, M110402, M110403, M110404, M110405, M110406, M110407, M110408, M110409, M110410, M110411, M110412, M110413, M110414, M110415, M110416, M110417, M110418, M110419, M110420, M110421, M110422, M110423, M110424, M110425, M110426, M110427, M110428, M110429, M110430, M110431, M110432, M110433, M110434, M110435, M110436, M110437, M110438, M110439, M110440, M110441, M110442, M110443, M110444, M110445, M110446, M110447, M110448, M110449, M110450, M110451, M110452, M110453, M110454, M110455, M110456, M110457, M110458, M110459, M110460, M110461, M110462, M110463, M110464, M110465, M110466, M110467, M110468, M110469, M110470, M110471, M110472, M110473, M110474, M110475, M110476, M110477, M110496, M110497, M110498, M110499, M110500, M110501, M110502, M110503, M110504, M110505, M110506, M110507, M110508, M110509, M110510, M110511, M110512, M110513, M110514, M110515, M110516, M110517, M110518, M110519, M110520, M110521, M110522, M110523, M110524, M110525, M110526, M110527, M110528, M110529, M110530, M110531, M110532, M110533, M110534, M110535, M110536, M110537, M110538, M110539, M110540, M110542, M110543, M110544, M110545, M110546, M110547, M110548, M110549, M110550, M110551, M110552, M110553, M110554, M110555, M110556, M110557, M110558, M110559, M110560, M110561, M110562, M110563, M110564, M110565, M110566, M110567, M110568, M110569, M110570, M110571, M110572, M110573, M110574, M110575, M110576, M110577, M110578, M110579, M110580, M110581, M110582, M110583, M110584, M110585, M110586, M110587, M110588, M110589, M110590, M110591, M110592, M110593, M110594, M110595, M110596, M110597, M110598, M110599, M110600, M110601, M110602, M110603, M110604, M110605, M110606, M110607, M110608, M110609, M110610, M110611, M110612, M110613, M110614, M110615, M110616, M110617, M110618, M110619, M110620, M110621, M110622, M110623, M110624, M110625, M110626, M110627, M110628, M110629, M110630, M110631, M110632, M110633, M110634, M110635, M110636, M110637, M110638, M110639, M110640, M110641, M110642, M110643, M110644, M110645, M110646, M110647, M110648, M110649, M110650, M110651, M110652, M110653, M110654, M110655, M110656, M110657, M110658, M110659, M110660, M110661, M110662, M110663, M110664, M110665, M110666, M110667, M110668, M110669, M110670, M110671, M110672, M110673, M110674, M110675, M110676, M110677, M110678, M110679, M110680, M110681, M110682, M110683, M110684, M110685, M110686, M110687, M110688, M110689, M110690, M110691, M110692, M110693, M110694, M110695, M110696, M110697, M110698, M110699, M110700, M110701, M110702, M110703, M110704, M110705, M110706, M110707, M110708, M110709, M110710, M110711, M110712, M110713, M110714, M110715, M110716, M110717, M110718, M110719, M110720, M110721, M110722, M110723, M110724, M110725, M110726, M110727, M110728, M110729, M110730, M110731, M110732, M110733, M110734, M110735, M110736, M110737, M110738, M110739, M110740, M110741, M110742, M110743, M110744, M110745, M110746, M110747, M110748, M110749, M110750, M110751, M110752, M110753, M110754, M110755, M110756, M110757, M110758, M110759, M110760, M110761, M110762, M110763, M110764, M110765, M110766, M110767, M110768, M110769, M110770, M110771, M110772, M110773, M110774, M110775, M110776, M110777, M110778, M110779, M110780, M110781, M110782, M110783, M110784, M110785, M110786, M110787, M110788, M110789, M110790, M110791, M110792, M110793, M110794, M110795, M110796, M110797, M110798, M110799, M110800, M110801, M110802, M110803, M110804, M110805, M110806, M110807, M110808, M110809, M110810, M110811, M110830, M110831, M110832, M110833, M110834, M110835, M110836, M110837, M110838, M110839, M110840, M110841, M110842, M110843, M110844, M110845, M110846, M110847, M110848, M110849, M110850, M110851, M110852, M110853, M110854, M110855, M110856, M110857, M110858, M110859, M110860, M110861, M110862, M110863, M110864, M110865, M110866, M110867, M110868, M110869, M110870, M110871, M110872, M110873, M110874, M110875, M110876, M110877, M110878, M110879, M110880, M110881, M110882, M110883, M110884, M110885, M110886, M110887, M110888, M110889, M110890, M110891, M110892, M110893, M110894, M110895, M110896, M110897, M110898, M110899, M110900, M110901, M110902, M110903, M110904, M110905, M110906, M110907, M110908, M110909, M110910, M110911, M110912, M110913, M110914, M110915, M110916, M110917, M110918, M110919, M110920, M110921, M110922, M110923, M110924, M110925, M110926, M110927, M110928, M110929, M110930, M110931, M110932, M110933, M110934, M110935, M110936, M110937, M110938, M110939, M110940, M110941, M110942, M110943, M110944, M110945, M110946, M110947, M110948, M110949, M110950, M110951, M110952, M110953, M110954, M110955, M110956, M110957, M110958, M110959, M110960, M110961, M110962, M110963, M110964, M110979, M110980, M110981, M110982, M110983, M110984, M110985, M110986, M110987, M110988, M110989, M110990, M110991, M110992, M110993, M110994, M110995, M110996, M110997, M110998, M110999, M111001, M111002, M111003, M111004, M111005, M111006, M111007, M111008, M111009, M111010, M111011, M111012, M111013, M111014, M111015, M111016, M111017, M111018, M111019, M111020, M111021, M111022, M111023, M111050, M111051, M111052, M111053, M111054, M111055, M111056, M111057.M111058, M111059, M111060, M111061, M111062, M111063, M111065, M111066, M111067, M111068, M111069, M111070, M111071, M111072, M111073, M111074, M111075, M111076, M111077, M111078, M111079, M111080, M111081, M111082, M111083, M111084, M111085, M111086, M111087, M111088, M111089, M111090, M111091, M111092, M111093, M111094, M111095, M111096, M111097, M111098, M111099, M111100, M111101, M111102, M111103, M111104, M111105, M111106, M111107, M111108, M111109, M111110, M111111, M111112, M111113, M111114, M111115, M111116, M111117, M111118, M111119, M111120, M111121, M111123, M111124, M111125, M111126, M111127, M111128, M111129, M111130, M111131, M111132, M111133, M111134, M111135, M111136, M111137, M111138, M111139, M111200, M111201, M111202, M111203, M111204, M111205, M111206, M111207, M111208, M111209, M111210, M111211, M111212, M111213, M111214, M111215, M111216, M111217, M111218, M111219, M111220, M111221, M111222, M111223, M111224, M111225, M111226, M111227, M111228, M111229, M111230, M111231, M111232, M111233, M111234, M111235, M111236, M111237, M111238, M111239, M111240, M111241, M111242, M111243, M111244, M111274, M111275, M111276, M111277, M111278, M111279, M111280, M111281, M14219, M24414, M41954, M41997, M42007, M42026, M89382; d) 3500-0600-249, UDI/DI 10610586041297, Serial Numbers: M105549, M107427, M107454, M108007, M111000, M111122, M-8835, M-8836, M-9288, M-9556; e) 3500-0600-50, UDI/DI 30610586043288, Serial Numbers: M103386, M103389, M103403, M103991, M103992, M107612, M107613, M107614, M107615, M107616, M107617, M107618, M107619, M109030, M109035, M109791, M109792, M109793, M109794, M109795, M109796, M109797, M109798, M109799, M109800, M109801, M109802, M109803, M109985, M109986, M109987, M109988, M109989, M109990, M109991, M109992, M109993, M110084, M110085, M110086, M110087, M110223, M110224, M110225, M110226, M110227, M110228, M110229, M110230, M110231, M110232, M110233, M110234, M110235, M110236, M110374, M110375, M110478, M110479, M110480, M110481, M110482, M110483, M110484, M110485, M110486, M110487, M110488, M110489, M110490, M110491, M110492, M110493, M110494, M110495, M110813, M110814, M110815, M110816, M110817, M110818, M110819, M110820, M110821, M110822, M110823, M110824, M110825, M110826, M110827, M110828, M110829, M110967, M110968, M110969, M110970, M110971, M110972, M110973, M110974, M110975, M110976, M110977, M110978, M111035, M111036, M111037, M111038, M111039, M111040, M111041, M111042, M111043; f) 3500-0600-51, UDI/DI 10610586043291, Serial Numbers: M102816, M102835, M102850, M107637, M107638, M107639, M107640, M107641, M107642, M107643, M107644, M107645, M107826, M107827, M107828, M107829, M107830, M107831, M107832, M107833, M107834, M107835, M107836, M107837, M107838, M107839, M107840, M107976, M107977, M107978, M107979, M107980, M108612, M109894, M110282, M110283, M110376, M110377, M110378, M110379, M110380, M110381, M110382, M110383, M110384, M110385, M110386, M110387, M110541, M110812, M110965, M110966, M111034, M111044, M111045, M111046, M111047, M111048, M111049; g) 3500-0600-82, UDI/DI 10610586043017, Serial Numbers: M107411, M107761, M107897, M108553, M109317, M109431, M72223, M73231, M73301, M73379, M74507, M76467, M76481, M76486, M77680, M-9287, M-9300, M-9536; h) 3500-306, UDI/DI 10610586030055, Serial Numbers: M01062, M01179, M-0311, M-2340, M-2764, M37987, M38283, M38763, M38893, M43371, M43872, M50994, M55582, M61733, M-6340, M69524, M-7460, M76856, M94897, M97091, M99597; i) 3500-402, UDI/DI 10610586030031, Serial Numbers: 10610586030031; j) 3500-414, UDI/DI 10610586030017, Serial Numbers: M41342, M42291, M44778, M44903, M44945, M44950, M45023; k) 3500-415, UDI/DI 10610586031175, Serial Numbers: M02946, M39042, M49377, M49531, M49935, M57371, M57542, M57687, M57746, M57766, M57804, M57839, M65407, M76972, M87039, M90010, M90569, M99702, M99914; l) 3500-500, UDI/DI 10610586032318, Serial Numbers: M-0109, M-0800, M-0864, M-2075, M57368, M57797, M57802, M-6608, M67850, M67881, M-7055, M-7063, M-7064, M-7066, M-7067, M-7072, M-7107, M-7145, M-7146, M71972, M71981, M71993, M-7211, M73697, M-7564, M-7565, M-7566, M-7571, M-7581, M-7582, M-7583, M-7584, M-7683, M-7687, M-7706, M-7751, M-7752, M-7753, M-7754, M-7755, M77637, M-7781, M-7786, M-7787, M-7788, M-7789, M-7790, M78486, M78904, M-7929, M-7930, M-7932, M-7933, M-7934, M-7935, M-7936, M-7950, M-7978, M-7979, M-7981, M-7987, M-7988, M83444, M83558, M84320, M84407, M84546, M-8485, M-8494, M-8528, M-8529, M85329, M85332, M-8548, M-8557, M-8597, M-8638, M-8810, M-8826, M-8827, M-8828, M-8829, M-8830, M-8831, M-8832, M-8837, M-8838, M-8839, M-8840, M-8841, M-8842, M-8843, M-8844, M-8845, M-8846, M-8847, M-8848, M-8849, M-8850, M-8851, M-8852, M-8853, M-8854, M-8855, M-8856, M-8857, M-8858, M-8859, M-8860, M-8861, M-8862, M-8863, M-8864, M-8865, M-8866, M-8867, M-8868, M-8869, M-8870, M-8871, M-8872, M-8873, M-8874, M-8875, M-8876, M-8877, M-8878, M-8879, M-8880, M-8881, M-8882, M-8883, M-8884, M-8885, M-8892, M-8900, M-8905, M-8906, M-8986, M-8990, M-9026, M-9035, M-9050, M-9079, M-9085, M-9091, M-9100, M-9101, M-9163, M-9164, M-9211, M-9232, M-9233, M-9234, M-9235, M-9236, M-9237, M-9238, M-9239, M-9240, M-9241, M-9242, M-9243, M-9244, M-9245, M-9246, M-9247, M-9248, M-9249, M-9250, M-9251, M-9252, M-9253, M-9254, M-9255, M-9256, M-9257, M-9258, M-9259, M-9260, M-9261, M-9262, M-9263, M-9264, M-9265, M-9266, M-9267, M-9268, M-9269, M-9270, M-9271, M-9272, M-9273, M-9274, M-9275, M-9276, M-9277, M-9278, M-9279, M-9280, M-9281, M-9282, M-9283, M-9289, M-9290, M-9291, M-9292, M-9293, M-9294, M-9295, M-9296, M-9297, M-9298, M-9299, M-9305, M-9306, M-9307, M-9308, M-9309, M-9310, M-9311, M-9312, M-9313, M-9314, M-9315, M-9316, M-9317, M-9318, M-9319, M-9320, M-9321, M-9322, M-9323, M-9324, M-9325, M-9326, M-9327, M-9328, M-9329, M-9330, M-9331, M-9332, M-9333, M-9334, M-9335, M-9336, M-9337, M-9338, M-9339, M-9340, M-9341, M-9342, M-9343, M-9344, M-9345, M-9346, M-9347, M-9348, M-9349, M-9350, M-9351, M-9352, M-9353, M-9354, M-9355, M-9356, M-9357, M-9358, M-9359, M-9360, M-9361, M-9362, M-9363, M-9364, M-9365, M-9366, M-9367, M-9368, M-9369, M-9370, M-9371, M-9372, M-9373, M-9374, M-9375, M-9376, M-9377, M-9378, M-9379, M-9380, M-9381, M-9382, M-9383, M-9384, M-9385, M-9386, M-9387, M-9388, M-9389, M-9390, M-9391, M-9392, M-9393, M-9394, M-9395, M-9396, M-9397, M-9398, M-9399, M-9400, M-9401, M-9402, M-9403, M-9404, M-9405, M-9407, M-9408, M-9409, M-9410, M-9411, M-9412, M-9413, M-9414, M-9415, M-9416, M-9417, M-9418, M-9419, M-9420, M-9421, M-9422, M-9423, M-9424, M-9425, M-9426, M-9427, M-9428, M-9429, M-9430, M-9431, M-9432, M-9433, M-9434, M-9435, M-9436, M-9437, M-9438, M-9439, M-9440, M-9441, M-9442, M-9443, M-9444, M-9445, M-9446, M-9447, M-9448, M-9449, M-9450, M-9451, M-9452, M-9453, M-9454, M-9455, M-9456, M-9457, M-9458, M-9459, M-9460, M-9461, M-9462, M-9463, M-9464, M-9465, M-9466, M-9467, M-9468, M-9469, M-9470, M-9471, M-9472, M-9473, M-9474, M-9475, M-9476, M-9477, M-9478, M-9479, M-9480, M-9481, M-9482, M-9483, M-9484, M-9485, M-9486, M-9487, M-9488, M-9489, M-9490, M-9491, M-9492, M-9493, M-9494, M-9495, M-9496, M-9497, M-9498, M-9499, M-9500, M95001, M-9501, M-9502, M-9503, M-9504, M-9505, M-9506, M-9507, M-9508, M-9509, M-9510, M-9511, M-9512, M-9513, M-9514, M-9515, M-9516, M-9517, M-9518, M-9519, M-9520, M-9521, M-9522, M-9523, M-9524, M-9525, M-9526, M-9527, M-9528, M-9529, M-9530, M-9531, M-9532, M-9533, M-9534, M-9535, M-9537, M-9538, M-9539, M-9540, M-9541, M-9542, M-9543, M-9544, M-9545, M-9546, M-9547, M-9548, M-9549, M-9550, M-9552, M-9553, M-9554, M-9557, M-9558, M-9559, M-9560, M-9561, M-9562, M-9563, M-9564, M-9565, M-9566, M-9567, M-9568, M-9569, M-9570, M-9571, M-9572, M-9573, M95938, M97253, M97254, M97295, M98443; m) 3500E, UDI/DI 10610586031755, Serial Numbers: M05377, M38385, M51141; n) 3500VX-306, UDI/DI 10610586031038, Serial Numbers: M03244; o) 3500VX-500, UDI/DI 10610586032325.Serial Numbers: M-9304
• Recalling Firm/ Manufacturer: Smiths Medical ASD Inc.; 6000 Nathan Ln N; Minneapolis MN 55442-1690
• For Additional Information Contact: icumed.custhelp.com/app/market¿ action; 763-383-3072
• Manufacturer Reason for Recall: Medfusion Model 4000, 3500, and 3010 pumps manufactured or serviced with Barrel Clamp Guide (Part Number G6000716), Lot Numbers P0407365, P0486670, and P0561740 may contain a molding defect that could potentially lead to slippage of the spring within the barrel clamp assembly. If this occurs, it could result in the inability of the pump to recognize a syringe or the pump may misidentify the size of the syringe loaded.
• FDA Determined Cause: Process control
• Action: Smiths Medical issued an Updated UREGNT MEDICAL DEVICE CORRECTION notice to its consignees on 12/19/2023 via US mail and email. The notice explained the issue, potential risk, and requested the following actions be taken: "Customer Required Actions - Medfusion Infusion Pumps: 1. Locate any affected Medfusion Syringe Pumps that may be in your possession by referring to the list of affected devices included with the Response Form. This list includes any specific pump model/serial number(s) your organization purchased that were manufactured or serviced with potentially affected Barrel Clamp Guides. Each pump has a unique serial number found on the label on the bottom of the pump. 2. You may continue to use the pumps but utilize the Syringe Verification Reference Tool originally included with the 2018 Notice (also provided as Attachment 2 of this communication) until pumps containing potentially affected Barrel Clamp Guides are repaired. Customer Required Actions - Individually Sold Barrel Clamp Guides: 1. Locate any affected Barrel Clamp Guide (Part Number G6000716) lots in your parts inventory or within the Medfusion Syringe Pump(s) you have repaired at your facility. NOTE - If you have purchased affected individually sold Barrel Clamp Guides, the Response Form included with this notice will indicate the order numbers shipped to your organization and a Return Label will be provided. 2. If any potentially affected Barrel Clamp Guides have already been installed in pumps, you may continue to use the pumps, but utilize the Syringe Verification Reference Tool originally included with the 2018 Notice (also provided as Attachment 2 of this communication) until the pumps installed with potentially affected Barrel Clamp Guides are repaired. If you have affected devices, please contact Smiths Medical for repair of the pump." "DISTRIBUTORS: If you have distributed potentially affected products to your customers, please immediately forward this notice to them. Ask them to c
• Quantity in Commerce: 3821 pumps
• Distribution: Worldwide distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = FRN