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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93771

4 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
December 19, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Smiths Medical ASD Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

4 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 4

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

Z-1540-2024
Recall number
Z-1540-2024
Initiated
December 19, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Smiths Medical ASD Inc.
Quantity
3821 pumps

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

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-882

Distribution pattern

Worldwide distribution.

device · product 2 of 4

Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

Z-1541-2024
Recall number
Z-1541-2024
Initiated
December 19, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Smiths Medical ASD Inc.
Quantity
7160 pumps

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

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) 4000-0101-249, UDI/DI 10610586040078, Serial Numbers: 2035426; b) 4000-0101-50, UDI/DI 10610586040054, Serial Numbers: 2033894; c) 4000-0101-51, UDI/DI 10610586040818, Serial Numbers: 2002706, 2004098, 2006133, 2006382, 2007411, 2008160, 2009040, 2009070, 2009661, 2009709, 2009723, 2009734, 2009997, 2010837, 2011049, 2011262, 2012096, 2013299, 2013805, 2020628, 2020630, 2020631, 2020972, 2023768, 2023983, 2023984, 2023985, 2024844, 2024913, 2024914, 2025040, 2026921, 2026922, 2026923, 2026924, 2026925, 2026926, 2026927, 2026928, 2026929, 2026930, 2026931, 2026934, 2026935, 2026936, 2026937, 2026938, 2026939, 2026940, 2026941, 2026942, 2026943, 2026944, 2026945, 2026946, 2026947, 2026948, 2026949, 2026950, 2026951, 2026952, 2026953, 2030198, 2031172, 2031173, 2032385, 2032622, 2034615, 2034616, 2034617, 2034618, 2034619, 2034620, 2034621, 2034622, 2034623, 2034624, 2034625, 2034716, 2034717, 2034718, 2034719, 2034720, 2034721, 2034722, 2034723, 2034724, 2034725, 2034726, 2034727, 2034728, 2034729, 2034730, 2034731, 2034732, 2034733, 2034734, 2034735, 2034736, 2034737, 2034738, 2034739, 2034740, 2034741, 2034742, 2034743, 2034744, 2034745, 2034926, 2034927, 2034928, 2034929, 2034930, 2034931, 2034932; d) 4000-0105-249, UDI/DI 10610586043581, Serial Numbers: 2026365, 2027405, 2035029; e) 4000-0105-50, UDI/DI none, Serial Numbers: 2022912, 2022913, 2022914; f) 4000-0105-51, UDI/DI 10610586043567, Serial Numbers: 2019150, 2019283, 2019287, 2019294, 2019299, 2019304, 2019309, 2019369, 2019471, 2019694, 2019729, 2019761, 2019777, 2019807, 2019808, 2019883, 2020096, 2020132, 2020153, 2020154, 2020211, 2020218, 2020259, 2020328, 2020348, 2020355, 2020365, 2020423, 2020426, 2020496, 2020528, 2020529, 2020530, 2020531, 2020532, 2020533, 2020534, 2020535, 2020536, 2020537, 2020543, 2020583, 2020592, 2020626, 2021417, 2022163, 2022883, 2022885, 2022930, 2022932, 2022936, 2022937, 2022940, 2022941, 2022946, 2022947, 2022948, 2022949, 2022950, 2022952, 2022953, 2022954, 2022964, 2022967, 2022968, 2022969, 2022971, 2022972, 2022973, 2022974, 2022975, 2022977, 2022982, 2022987, 2022988, 2022990, 2023112, 2023211, 2023333, 2023355, 2023358, 2023382, 2023400, 2023454, 2023465, 2023466, 2023467, 2023468, 2023469, 2023470, 2023472, 2023473, 2023474, 2023475, 2023476, 2023477, 2023478, 2023479, 2023480, 2023481, 2023482, 2023483, 2023484, 2023485, 2023486, 2023487, 2023488, 2023489, 2023490, 2023491, 2023492, 2023493, 2023494, 2023725, 2023834, 2024241, 2024308, 2024356, 2024417, 2024544, 2024545, 2024546, 2024547, 2024548, 2024549, 2024551, 2024552, 2024553, 2024554, 2024555, 2024556, 2024557, 2024558, 2024559, 2024560, 2024561, 2024562, 2024563, 2024564, 2024565, 2024567, 2024568, 2024569, 2024570, 2024571, 2024572, 2024574, 2024575, 2024576, 2024577, 2024578, 2024579, 2024580, 2024581, 2024583, 2024664, 2024725, 2024727, 2024731, 2024812, 2024984, 2024985, 2025003, 2025053, 2025054, 2025057, 2025133, 2025144, 2025161, 2025219, 2025220, 2025244, 2025255, 2025270, 2025282, 2025304, 2025550, 2025559, 2025776, 2025799, 2025999, 2026046, 2026047, 2026048, 2026049, 2026050, 2026051, 2026052, 2026053, 2026054, 2026055, 2026056, 2026057, 2026058, 2026059, 2026060, 2026061, 2026062, 2026063, 2026064, 2026065, 2026066, 2026067, 2026068, 2026069, 2026070, 2026071, 2026072, 2026073, 2026074, 2026075, 2026076, 2026077, 2026078, 2026079, 2026080, 2026081, 2026082, 2026083, 2026084, 2026085, 2026086, 2026087, 2026088, 2026089, 2026090, 2026091, 2026092, 2026093, 2026094, 2026095, 2026096, 2026097, 2026098, 2026099, 2026100, 2026101, 2026102, 2026103, 2026104, 2026105, 2026106, 2026107, 2026108, 2026109, 2026110, 2026111, 2026112, 2026113, 2026114, 2026115, 2026116, 2026117, 2026118, 2026119, 2026120, 2026121, 2026122, 2026123, 2026124, 2026125, 2026126, 2026127, 2026128, 2026129, 2026130, 2026131, 2026132, 2026133, 2026134, 2026135, 2026136, 2026137, 2026138, 2026139, 2026140, 2026141, 2026142, 2026143, 2026145, 2026146, 2026147, 2026148, 2026149, 2026150, 2026151, 2026152, 2026153, 2026154, 2026156, 2026157, 2026158, 2026159, 2026160, 2026161, 2026162, 2026163, 2026164, 2026165, 2026166, 2026167, 2026168, 2026169, 2026170, 2026171, 2026173, 2026174, 2026175, 2026176, 2026177, 2026178, 2026179, 2026180, 2026181, 2026182, 2026183, 2026184, 2026185, 2026186, 2026187, 2026188, 2026189, 2026190, 2026191, 2026192, 2026193, 2026194, 2026195, 2026196, 2026197, 2026198, 2026199, 2026200, 2026201, 2026202, 2026203, 2026204, 2026205, 2026206, 2026207, 2026208, 2026209, 2026210, 2026211, 2026212, 2026213, 2026214, 2026215, 2026216, 2026217, 2026218, 2026219, 2026220, 2026221, 2026222, 2026223, 2026224, 2026225, 2026226, 2026227, 2026228, 2026229, 2026230, 2026231, 2026232, 2026233, 2026234, 2026235, 2026236, 2026237, 2026238, 2026239, 2026240, 2026241, 2026243, 2026244, 2026245, 2026246, 2026247, 2026248, 2026249, 2026250, 2026251, 2026252, 2026253, 2026254, 2026255, 2026256, 2026257, 2026258, 2026259, 2026260, 2026261, 2026262, 2026263, 2026265, 2026266, 2026267, 2026268, 2026269, 2026270, 2026271, 2026272, 2026273, 2026275, 2026276, 2026277, 2026278, 2026279, 2026280, 2026281, 2026282, 2026283, 2026284, 2026285, 2026286, 2026287, 2026288, 2026289, 2026290, 2026291, 2026294, 2026295, 2026296, 2026297, 2026298, 2026299, 2026300, 2026301, 2026302, 2026303, 2026304, 2026305, 2026306, 2026307, 2026308, 2026309, 2026310, 2026311, 2026312, 2026313, 2026315, 2026316, 2026317, 2026318, 2026319, 2026320, 2026321, 2026322, 2026323, 2026324, 2026325, 2026326, 2026327, 2026328, 2026329, 2026330, 2026331, 2026332, 2026333, 2026334, 2026335, 2026336, 2026337, 2026338, 2026339, 2026340, 2026341, 2026342, 2026343, 2026344, 2026345, 2026346, 2026347, 2026348, 2026349, 2026350, 2026351, 2026352, 2026353, 2026354, 2026355, 2026356, 2026357, 2026358, 2026359, 2026360, 2026361, 2026362, 2026363, 2026364, 2026366, 2026367, 2026368, 2026369, 2026370, 2026371, 2026372, 2026374, 2026375, 2026376, 2026377, 2026378, 2026379, 2026380, 2026381, 2026382, 2026383, 2026384, 2026386, 2026387, 2026388, 2026389, 2026390, 2026391, 2026392, 2026393, 2026394, 2026395, 2026396, 2026397, 2026398, 2026399, 2026400, 2026401, 2026402, 2026403, 2026405, 2026406, 2026407, 2026408, 2026409, 2026410, 2026411, 2026412, 2026413, 2026414, 2026415, 2026416, 2026417, 2026418, 2026419, 2026420, 2026422, 2026423, 2026424, 2026425, 2026426, 2026427, 2026428, 2026429, 2026430, 2026431, 2026432, 2026434, 2026435, 2026436, 2026437, 2026438, 2026439, 2026440, 2026441, 2026442, 2026443, 2026444, 2026445, 2026446, 2026447, 2026448, 2026449, 2026450, 2026451, 2026452, 2026453, 2026454, 2026455, 2026456, 2026457, 2026458, 2026459, 2026460, 2026461, 2026462, 2026463, 2026464, 2026465, 2026466, 2026467, 2026468, 2026469, 2026470, 2026471, 2026472, 2026473, 2026474, 2026475, 2026476, 2026477, 2026478, 2026479, 2026480, 2026481, 2026482, 2026483, 2026484, 2026485, 2026486, 2026487, 2026488, 2026489, 2026490, 2026491, 2026492, 2026493, 2026494, 2026495, 2026496, 2026497, 2026498, 2026499, 2026500, 2026501, 2026502, 2026503, 2026504, 2026505, 2026506, 2026507, 2026508, 2026509, 2026510, 2026511, 2026512, 2026513, 2026514, 2026515, 2026516, 2026517, 2026518, 2026519, 2026520, 2026521, 2026522, 2026523, 2026524, 2026525, 2026526, 2026527, 2026528, 2026529, 2026530, 2026531, 2026532, 2026533, 2026534, 2026535, 2026536, 2026537, 2026538, 2026539, 2026540, 2026541, 2026542, 2026543, 2026544, 2026545, 2026546, 2026547, 2026548, 2026549, 2026550, 2026551, 2026552, 2026553, 2026554, 2026555, 2026556, 2026557, 2026558, 2026559, 2026560, 2026561, 2026562, 2026563, 2026564, 2026565, 2026566, 2026567, 2026568, 2026569, 2026570, 2026571, 2026572, 2026573, 2026574, 2026575, 2026576, 2026577, 2026578, 2026579, 2026580, 2026581, 2026582, 2026583, 2026584, 2026585, 2026586, 2026587, 2026588, 2026589, 2026590, 2026591, 2026592, 2026593, 2026594, 2026595, 2026596, 2026597, 2026598, 2026599, 2026600, 2026601, 2026602, 2026603, 2026604, 2026605, 2026606, 2026607, 2026608, 2026609, 2026610, 2026611, 2026612, 2026613, 2026614, 2026615, 2026616, 2026617, 2026618, 2026619, 2026620, 2026621, 2026622, 2026623, 2026624, 2026625, 2026626, 2026627, 2026628, 2026629, 2026630, 2026631, 2026632, 2026633, 2026634, 2026635, 2026636, 2026637, 2026638, 2026639, 2026640, 2026641, 2026642, 2026643, 2026644, 2026645, 2026646, 2026647, 2026648, 2026649, 2026650, 2026651, 2026652, 2026653, 2026654, 2026655, 2026656, 2026657, 2026658, 2026659, 2026660, 2026661, 2026662, 2026663, 2026664, 2026665, 2026666, 2026667, 2026668, 2026669, 2026670, 2026671, 2026672, 2026673, 2026674, 2026675, 2026676, 2026677, 2026678, 2026679, 2026680, 2026681, 2026682, 2026683, 2026684, 2026685, 2026686, 2026687, 2026688, 2026689, 2026692, 2026693, 2026694, 2026695, 2026696, 2026697, 2026698, 2026699, 2026700, 2026701, 2026702, 2026703, 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2030681, 2030682, 2030684, 2030714, 2030715, 2030720, 2030744, 2030783, 2030788, 2030895, 2030896, 2030925, 2030927, 2030955, 2035670, 2035671, 2035672, 2035673, 2035674, 2035675, 2035676, 2035677, 2035678, 2035679, 2035680, 2035681, 2035682, 2035683, 2035684, 2035685, 2035686, 2035687, 2035688, 2035689, 2035690, 2035691, 2036026, 2036252, 2036253; g) 4000-0105-78, UDI/DI 10610586043574, Serial Numbers: 2026172, 2026433, 2032847, 2032881, 2033072, 2033132, 2035215, 2035443, 2035448, 2035454, 2035457, 2035458, 2035501, 2036239, 2036483, 2036494, 2036626; h) 4000-0106-00, UDI/DI 15019517070750, Serial Numbers: 2026144, 2026691, 2027396, 2032794, 2032811, 2032870, 2032889, 2032952, 2032957, 2032958, 2032992, 2033005, 2033065, 2033073, 2033123, 2033595, 2033596, 2033597, 2033598, 2035027, 2035028, 2035030, 2035032, 2035034, 2035037, 2035038, 2035424, 2035436, 2035463, 2035464, 2035478, 2035518, 2035540, 2035636, 2035669, 2036330, 2036378, 2036402, 2036478, 2036641, 2036671, 2036940, 2037084, 2037180, 2037234, 2037361, 2037472, 2037477, 2037523, 2037710, 2037828, 2037987, 2038016, 2038038; i) 4000-0106-01, UDI/DI 15019517069624, Serial Numbers: 2022965, 2026155, 2026242, 2026264, 2026274, 2026292, 2026293, 2026314, 2026373, 2026385, 2026404, 2026421, 2026932, 2026933, 2027025, 2027098, 2027163, 2027224, 2027225, 2027268, 2027331, 2027332, 2027333, 2027456, 2027459, 2027512, 2027594, 2027596, 2027601, 2027624, 2027674, 2027750, 2028841, 2029104, 2029133, 2030409, 2030418, 2030421, 2030435, 2030464, 2030466, 2030467, 2030492, 2030493, 2030500, 2030501, 2030509, 2030514, 2030522, 2030554, 2030560, 2030563, 2030573, 2030579, 2030580, 2030594, 2030599, 2030601, 2030606, 2030617, 2030621, 2030804, 2030805, 2030818, 2030824, 2030831, 2030846, 2030850, 2030858, 2030860, 2030865, 2030868, 2030882, 2030889, 2030991, 2030992, 2030997, 2031008, 2031010, 2031016, 2031021, 2031031, 2031040, 2031045, 2031065, 2031071, 2031095, 2031103, 2031119, 2031131, 2031134, 2031159, 2031189, 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Distribution pattern

Worldwide distribution.

device · product 3 of 4

Smiths Medical Model 3010 Syringe pumps: a. Protege Model 3010, b. Medfusion Model 3010A, c. Protege UK Model 3010E

Z-1542-2024
Recall number
Z-1542-2024
Initiated
December 19, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Smiths Medical ASD Inc.
Quantity
27 pumps

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

All serial numbers for pumps manufactured or serviced with these potentially affected Barrel Clamp Guides between Jul-2016 and Apr-2021. a. 3010, UDI/DI none, Serial Numbers: M03315, M03910; b. 3010A, UDI/DI 10610586032097, Serial Numbers: M04601, M05551, M05782, M06829, M07259, M07334, M07339, M07342, M07345, M07371, M08269, M08750, M08815, M10253, M10267, M10871, M10876, M10965, M11872, M11896, M11899, M11901, M11905, M11915; c. 3010E, UDI/DI none, Serial Numbers: M05179

Distribution pattern

Worldwide distribution.

device · product 4 of 4

Smiths Medical Medfusion Guide Barrel Clamp, Item number G6000716

Z-1543-2024
Recall number
Z-1543-2024
Initiated
December 19, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Smiths Medical ASD Inc.
Quantity
1842 guide barrel clamps

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Lot Numbers: P0407365, P0486670, P0561740

Distribution pattern

Worldwide distribution.