Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600... — FDA record Z-1540-2024

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Dec 19, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

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
Reason
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.
Classification
Class II
Recalling firm
Smiths Medical ASD Inc.
Quantity
3821 pumps
Agency-reported status
Ongoing
Source record identifier
Z-1540-2024

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label fieldDetails supplied by the agency
Lot, code or applicabilityAll 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, ...

The agency lot list is longer than this excerpt. Read the complete list at the official source.

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

Worldwide distribution.

No US distribution state could be established from this record. Check the official notice.

Dates in the source

Report date
Apr 24, 2024
Recall initiation date
Dec 19, 2023
Center classification date
Apr 15, 2024

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

Related records