Recall archive / FDA device enforcement
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
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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, ... |
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.