--- title: "Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model ... — FDA record Z-1271-2022 | Is It on Recall" description: "Multiple issues with the potential for interruption of therapy or over-infusion: 1. Primary Audible Alarm (PAA), 2. Unanticipated Depleted Battery Alarms, 3. Ti" url: https://isitonrecall.com/recall/fda-device-z-1271-2022-medfusion-syringe-pump-model-model-4000-0100-50-model-4000-0101-249-model-4000-0101-50-model-4000-01/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement # Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model ... — FDA record Z-1271-2022 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 Apr 18, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## What the record says - **Product**: Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231 - **Reason**: Multiple issues with the potential for interruption of therapy or over-infusion: 1. Primary Audible Alarm (PAA), 2. Unanticipated Depleted Battery Alarms, 3. Time Base Alarm, 4. Intermittent Volume Over Time (IVOT) - Infusion Continues after System Failure, 5. Clearing of Program Volume Delivered (PVD), 6. False Alarm for Rate Below Recommended Minimum for Syringe Size, 7. Incorrect Bolus or Loading Dose Time Display, 8. Domain Name Server (DNS) Port 1001 - **Classification**: Class I - **Recalling firm**: Smiths Medical ASD Inc. - **Quantity**: 58671 units - **Agency-reported status**: Ongoing - **Source record identifier**: Z-1271-2022 [Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1271-2022%22) [What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice. ## Lot and product identifiers | Label field | Details supplied by the agency | | --- | --- | | Lot, code or applicability | Model 4000-0100-50: UDI 061058603532, Serial Numbers: 2000380, 2000342, 2000351, 2000485, 2002080, 2000501, 2000275, 2002089, 2000528, 2000386, 2002086, 2000555, 2002083, 2000530, 2000495, 2002084, 2002087, 2000452, 2002092, 2000489, 2000283, 2002098, 2000309, 2000315, 2000434, 2002094, 2000442, 2000427, 2000334, 2000388, 2000415, 2000270, 2000364, 2000401, 2002103, 2000377, 2000579, 2002101, 2000352, 2002090, 2000474, 2000456, 2002102, 2000307, 2000323, 2000368, 2000337, 2000429, 2000466, 2000296, 2000294, 2000340, 2000457, 2000412, 2000339, 2000543, 2000470, 2000319, 2000399, 2000539, 2002095, 2000404, 2000384, 2000250, 2000328, 2002097, 2000564, 2000266, 2000350, 2000446, 2000372, 2000569, 2000289, 2000344, 2000253, 2000416, 2000259, 2000367, 2000293, 2000418, 2000422, 2000459, 2000463, 2000435, 2000335, 2000295, 2000562, 2000394, 2000407, 2000510, 2000373, 2000249, 2000292, 2000301, 2000557, 2000303, 2000378, 2000327, 2000538, 2000263, 2000410, 2000420, 2000424, 2000514, 2000536, 2000488, 2000448, 2000262, 2000354, 2000271, 2002091, 2002093, 2002096, 2002099, 2002100, 2002085, 2002081, 2002082, 2000534, 2000535, 2000580, 2000581, 2000582, 2000583, 2000584, 2000567, 2000568, 2000570, 2000571, 2000572, 2000573, 2000574, 2000575, 2000576, 2000577, 2000578, 2000505, 2000506, 2000507, 2000508, 2000509, 2000511, 2000512, 2000513, 2000515, 2000516, 2000517, 2000518, 2000519, 2000520, 2000521, 2000522, 2000523, 2000524, 2000525, 2000526, 2000527, 2000529, 2000531, 2000532, 2000533, 2000537, 2000540, 2000541, 2000542, 2000544, 2000545, 2000546, 2000547, 2000548, 2000549, 2000550, 2000551, 2000552, 2000553, 2000554, 2000556, 2000558, 2000559, 2000560, 2000561, 2000563, 2000565, 2000566, 2000445, 2000447, 2000449, 2000450, 2000451, 2000453, 2000454, 2000455, 2000458, 2000460, 2000461, 2000462, 2000464, 2000465, 2000467, 2000468, 2000469, 2000471, 2000472, 2000473, 2000475, 2000476, 2000477, 2000478, 2000479, 2000480, 2000481, 2000482, 2000483, 2000484, 2000486, 2000487, 2000490, 2000491, 2000492, 2000493, 2000494, 2000496, 2000497, 2000498, 2000499, 2000500, 2000502, 2000503, 2000504, 2000305, 2000330, 2000333, 2000357, 2000361, 2000362, 2000365, 2000369, 2000391, 2000397, 2000398, 2000400, 2000402, 2000405, 2000414, 2000419, 2000423, 2000425, 2000430, 2000440, 2000441, 2000443, 2000245, 2000246, 2000247, 2000248, 2000251, 2000252, 2000254, 2000255, 2000256, 2000257, 2000258, 2000260, 2000261, 2000264, 2000265, 2000267, 2000268, 2000269, 2000272, 2000273, 2000274, 2000276, 2000277, 2000278, 2000279, 2000280, 2000281, 2000282, 2000284, 2000285, 2000286, 2000287, 2000288, 2000290, 2000291, 2000297, 2000298, 2000300, 2000302, 2000304, 2000308, 2000310, 2000311, 2000312, 2000313, 2000314, 2000317, 2000318, 2000320, 2000321, 2000322, 2000324, 2000325, 2000326, 2000329, 2000331, 2000332, 2000336, 2000338, 2000341, 2000343, 2000345, 2000346, 2000348, 2000353, 2000355, 2000358, 2000359, 2000360, 2000363, 2000366, 2000370, 2000371, 2000374, 2000375, 2000376, 2000379, 2000381, 2000383, 2000385, 2000387, 2000389, 2000390, 2000392, 2000393, 2000395, 2000396, 2000403, 2000408, 2000409, 2000413, 2000417, 2000426, 2000433; Model 4000-0101-249: UDI 061058604007, Serial Numbers: 2006483 Model 4000-0101-50: UDI 061058604005, Serial Numbers: 2004701, 2002059, 2004692, 2004700, 2004702, 2004703, 2004704, 2004706, 2004708, 2004698, 2004705, 2004699, 2004697, 2004691, 2004711, 2002052, 2002040, 2033894, 2020659, 2009109, 2004712, 2020658, 2002058, 2018439, 2012306, 2012307, 2012308, 2012309, 2012310, 2012311, 2012312, 2012313, 2012314, 2012315, 2012316, 2012317, 2012318, 2012319, 2012320, 2012321, 2004714, 2004715, 2004716, 2004717, 2004718, 2004719, 2004720, 2004721, 2004722, 2004723, 2004724, 2004725, 2004726, 2004727, 2004728, 2004729, 2004730, 2004731, 2004732, 2004733, 2004734, 2004735, 2004736, 2004737, 2004738, 2004739, 2004740, 2004741, 2004742, 2010232, 2010233, 2010234, 2010235, 2010236, 2010237, 2010238, 2010239, 2010240, 2010241, 2010242, 2010243, 2010244, 2010245, 2010246, 2010247, 2010248, 2010249, 2010250, 2010251, 2010252, 2010253, 2010254, 2002055, 2004678, 2004679, 2004680, 2004681, 2004682, 2004683, 2004684, 2004685, 2004686, 2004687, 2004688, 2004689, 2004690, 2004693, 2004694, 2002057, 2002056, 2002053, 2002054, 2002041, 2002039, 2002042, 2002043, 2002044, 2002045, 2002046, 2002047, 2002048, 2002049, 2002050, 2002051, 2002000, 2002001, 2002002, 2002003, 2002004, 2002005, 2002006, 2002007, 2002009, 2002010, 2002011, 2002012, 2002013, 2002014, 2002015, 2002016, 2002017, 2002018, 2002019, 2002020, 2002021, 2002022, 2002023; Model 4000-0101-51: UDI 061058604081, Serial Numbers: 2006244, 2019074, 2017326, 2017342, 2009632, 2015808, 2008103, 2008064, 2016913, 2023787, 2013675, 2013728, 2014343, 2014441, 2013612, 2014406, 2011697, 2011707, 2016904, 2016922, 2016942, 2013850, 2015442, 2007447, 2007684, 2008057, 2017211, 2005046, 2016886, 2016936, 2014464, 2012788, 2006628, 2006842, 2016758, 2015388, 2008224, 2008337, 2011358, 2002439, 2010042, 2009749, 2009762, 2013459, 2012409, 2012455, 2012497, 2002162, 2007409, 2010279, 2021064, 2004970, 2005247, 2005250, 2006653, 2006844, 2015489, 2023986, 2022797, 2010740, 2009694, 2016117, 2005192, 2006455, 2006656, 2007322, 2015468, 2005522, 2008328, 2009215, 2002112, 2007560, 2007670, 2007728, 2007695, 2013603, 2002641, 2009298, 2020963, 2020964, 2006663, 2007077, 2007244, 2007861, 2032629, 2015711, 2005365, 2013416, 2012226, 2002291, 2007547, 2007559, 2007567, 2007584, 2020641, 2017458, 2017482, 2012362, 2002330, 2007605, 2002188, 2002215, 2002237, 2007411, 2007474, 2007649, 2007801, 2013530, 2015476, 2016770, 2009785, 2011810, 2012602, 2006147, 2005599, 2005605, 2005612, 2020647, 2005034, 2016701, 2011999, 2016909, 2016976, 2016977, 2019031, 2019037, 2009529, 2007198, 2002659, 2006524, 2006571, 2015671, 2009022, 2009035, 2013101, 2011996, 2006464, 2006539, 2006543, 2006879, 2017113, 2007634, 2012006, 2016899, 2016932, 2013843, 2008028, 2016883, 2016787, 2008475, 2013455, 2007786, 2007809, 2007374, 2007764, 2002377, 2007805, 2011679, 2016907, 2020635, 2007432, 2002325, 2012004, 2013692, 2013817, 2013868, 2007575, 2007781, 2013653, 2009734, 2010167, 2011473, 2013669, 2013810, 2016982, 2013910, 2013913, 2017108, 2005315, 2003938, 2016745, 2023991, 2004354, 2004472, 2013743, 2014325, 2021069, 2013907, 2009211, 2004415, 2004616, 2004621, 2004187, 2004235, 2004249, 2004335, 2004336, 2004361, 2004372, 2004452, 2004458, 2004478, 2004532, 2004573, 2018081, 2014040, 2014079, 2013236, 2011993, 2011995, 2011997, 2012003, 2012005, 2016813, 2013929, 2005011, 2012993, 2011994, 2017020, 2007572, 2007641, 2007355, 2007415, 2007537, 2016772, 2007638, 2004637, 2013640, 2013661, 2013705, 2013815, 2013870, 2014330, 2007710, 2007726, 2009793, 2007645, 2010902, 2005845, 2003942, 2021376, 2009447, 2009695, 2022817, 2014243, 2004921, 2007846, 2009589, 2013639, 2013128, 2008382, 2004996, 2016711, 2004974, 2009519, 2016873, 2015056, 2015109, 2013898, 2015338, 2016881, 2016935, 2004776, 2004777, 2004779, 2011647, 2011651, 2016226, 2012175, 2012597, 2016878, 2016933, 2013878, 2013883, 2016914, 2009604, 2002448, 2009012, 2012477, 2012638, 2010276, 2013844, 2004667, 2008704, 2011557, 2012234, 2012375, 2013001, 2014465, 2008630, 2008908, 2008930, 2008693, 2020949, 2013247, 2009828, 2009836, 2010181, 2011479, 2012668, 2012930, 2013010, 2012752, 2012862, 2013190, 2002735, 2010668, 2002770, 2013425, 2009039, 2015426, 2009645, 2013634, 2023989, 2013873, 2016828, 2016831, 2008669, 2008229, 2007843, 2006333, 2011408, 2011480, 2004663, 2013112, 2016400, 2012794, 2016780, 2013179, 2004764, 2015857, 2015982, 2012746, 2013864, 2014415, 2016795, 2021031, 2013105, 2004771, 2013322, 2011444, 2011264, 2020935, 2020638, 2012884, 2016893, 2019024, 2019026, 2011265, 2011270, 2013539, 2008690, 2016506, 2012090, 2014542, 2004278, 2004633, 2011691, 2011696, 2016924, 2020984, 2011471, 2016916, 2017175, 2023997, 2013781, 2008392, 2017788, 2012813, 2012838, 2017238, 2012726, 2016790, 2012795, 2012830, 2016424, 2013993, 2017291, 2017299, 2011463, 2007040, 2010426, 2010539, 2015839, 2009388, 2010578, 2015444, 2012729, 2012996, 2013643, 2010600, 2015433, 2009839, 2009357, 2007048, 2012935, 2004955, 2006347, 2006264, 2011685, 2014435, 2013415, 2011714, 2016912, 2013757, 2014236, 2006247, 2013733, 2014282, 2016556, 2015471, 2021047, 2015699, 2009453, 2016474, 2002857, 2013720, 2013119, 2023995, 2007261, 2013831, 2014454, 2009459, 2009465, 2008458, 2017040, 2004762, 2016352, 2016637, 2014716, 2007106, 2005428, 2009031, 2013445, 2008409, 2010663, 2009787, 2009820, 2005424, 2012261, 2013438, 2017449, 2007838, 2014963, 2017432, 2016326, 2016480, 2006203, 2010149, 2013623, 2013668, 2013532, 2017009, 2023996, 2015224, 2012703, 2012954, 2013935, 2016360, 2017307, 2016715, 2017438, 2017996, 2006317, 2013074, 2006405, 2013672, 2013741, 2013921, 2013968, 2006918, 2007162, 2007295, 2007960, 2005143, 2017261, 2008634, 2014202, 2016894, 2016928, 2012012, 2011281, 2006286, 2008788, 2008904, 2020956, 2008642, 2020955, 2015142, 2016884, 2016903, 2022814, 2023779, 2002485, 2008652, 2008746, 2008827, 2008857, 2008880, 2008900, 2015105, 2016136, 2018066, 2016497, 2002465, 2002496, 2016159, 2010321, 2020950, 2014016, 2014166, 2013737, 2014431, 2004820, 2004252, 2004230, 2004240, 2004248, 2004288, 2004366, 2004459, 2004588, 2008017, 2013766, 2009609, 2004331, 2004398, 2004410, 2004447, 2004570, 2004775, 2016739, 2004535, 2013189, 2004594, 2017240, 2010335, 2010794, 2013434, 2013436, 2010675, 2009036, 2009094, 2013437, 2013440, 2013441, 2013443, 2016631, 2017755, 2006252, 2009042, 2009037, 2013687, 2008399, 2002681, 2021062, 2002482, 2002484, 2007583, 2014140, 2012814, 2013859, 2016983, 2013431, 2009702, 2013704, 2013840, 2012391, 2018411, 2010641, 2023999, 2003520, 2005553, 2017483, 2016897, 2018047, 2011826, 2002839, 2010183, 2016396, 2002611, 2011677, 2002406, 2016445, 2018054, 2005354, 2002208, 2007581, 2008310, 2002158, 2007680, 2013439, 2017829, 2007642, 2007709, 2007636, 2015336, 2016164, 2002716, 2005253, 2013830, 2004830, 2010509, 2010556, 2007425, 2007586, 2013435, 2013442, 2011070, 2009727, 2002599, 2013534, 2013836, 2003793, 2007201, 2017283, 2009443, 2009754, 2009832, 2015043, 2017016, 2013693, 2013862, 2004778, 2034716, 2004966, 2014470, 2009550, 2016347, 2016468, 2017946, 2006240, 2023993, 2017184, 2013067, 2004640, 2017095, 2009991, 2010005, 2010008, 2014273, 2011417, 2016876, 2009448, 2008405, 2017984, 2018042, 2014249, 2016523, 2013057, 2013096, 2012740, 2013719, 2013723, 2009438, 2011641, 2016323, 2016535, 2018008, 2014107, 2006270, 2012183, 2013043, 2013082, 2013677, 2014327, 2014339, 2014438, 2016421, 2012757, 2012828, 2013079, 2009509, 2018070, 2016465, 2016540, 2017433, 2006220, 2012810, 2013767, 2013866, 2013879, 2020980, 2017350, 2002423, 2002442, 2019034, 2009920, 2011295, 2016741, 2013660, 2013930, 2008001, 2013782, 2002369, 2016892, 2015377, 2015506, 2015963, 2002312, 2011260, 2015193, 2014241, 2011688, 2014446, 2016846, 2016872, 2008806, 2009029, 2015155, 2014439, 2003273, 2008658, 2008705, 2008972, 2020951, 2009021, 2007423, 2011674, 2008676, 2008836, 2008903, 2008949, 2020954, 2009766, 2016817, 2005772, 2008870, 2008397, 2016541, 2008837, 2008954, 2011252, 2016367, 2016670, 2013556, 2018716, 2008775, 2008879, 2008909, 2008968, 2013779, 2004904, 2012738, 2012844, 2012906, 2011337, 2016735, 2011835, 2007406, 2012866, 2013632, 2011256, 2013114, 2014240, 2016733, 2007352, 2007377, 2007532, 2007578, 2007688, 2007730, 2007774, 2015297, 2009524, 2010114, 2020933, 2007422, 2016791, 2017306, 2017245, 2013000, 2017094, 2016875, 2015130, 2013683, 2016569, 2018614, 2012742, 2004666, 2012991, 2010189, 2012671, 2012696, 2012715, 2013699, 2013731, 2008386, 2014239, 2007401, 2007607, 2018111, 2018791, 2017303, 2002119, 2002246, 2002336, 2007368, 2014912, 2017241, 2017281, 2017284, 2017285, 2017289, 2017300, 2017302, 2012592, 2007747, 2007810, 2010283, 2017447, 2013578, 2024926, 2013816, 2017235, 2017237, ... | The agency lot list is longer than this excerpt. [Read the complete list at the official source](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1271-2022%22). Match all identifying details in the current notice. A brand name alone is not enough. ## Distribution Worldwide distribution. US nationwide including US Virgin Islands, Countries of: AE, AL, AT, AU, BE, BM, BN, BS, CA, CH, CL, CY, CZ, DE, DK, DO, ES, FI, FR, GB, HK, HU, ID, IE, IL, IN, IR, IT, KR, KW, LB, LK, MU, MX, MY, NL, NZ, OM, PA, PH, PK, PL, PT, QA, SA, SE, SG, TR, TT, VI, and VN. States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address. - [Alaska](https://isitonrecall.com/state/alaska/) - [Alabama](https://isitonrecall.com/state/alabama/) - [Arkansas](https://isitonrecall.com/state/arkansas/) - [Arizona](https://isitonrecall.com/state/arizona/) - [California](https://isitonrecall.com/state/california/) - [Colorado](https://isitonrecall.com/state/colorado/) - [Connecticut](https://isitonrecall.com/state/connecticut/) - [Delaware](https://isitonrecall.com/state/delaware/) - [Florida](https://isitonrecall.com/state/florida/) - [Georgia](https://isitonrecall.com/state/georgia/) - [Hawaii](https://isitonrecall.com/state/hawaii/) - [Iowa](https://isitonrecall.com/state/iowa/) - [Idaho](https://isitonrecall.com/state/idaho/) - [Illinois](https://isitonrecall.com/state/illinois/) - [Indiana](https://isitonrecall.com/state/indiana/) - [Kansas](https://isitonrecall.com/state/kansas/) - [Kentucky](https://isitonrecall.com/state/kentucky/) - [Louisiana](https://isitonrecall.com/state/louisiana/) - [Massachusetts](https://isitonrecall.com/state/massachusetts/) - [Maryland](https://isitonrecall.com/state/maryland/) - [Maine](https://isitonrecall.com/state/maine/) - [Michigan](https://isitonrecall.com/state/michigan/) - [Minnesota](https://isitonrecall.com/state/minnesota/) - [Missouri](https://isitonrecall.com/state/missouri/) - [Mississippi](https://isitonrecall.com/state/mississippi/) - [Montana](https://isitonrecall.com/state/montana/) - [North Carolina](https://isitonrecall.com/state/north-carolina/) - [North Dakota](https://isitonrecall.com/state/north-dakota/) - [Nebraska](https://isitonrecall.com/state/nebraska/) - [New Hampshire](https://isitonrecall.com/state/new-hampshire/) - [New Jersey](https://isitonrecall.com/state/new-jersey/) - [New Mexico](https://isitonrecall.com/state/new-mexico/) - [Nevada](https://isitonrecall.com/state/nevada/) - [New York](https://isitonrecall.com/state/new-york/) - [Ohio](https://isitonrecall.com/state/ohio/) - [Oklahoma](https://isitonrecall.com/state/oklahoma/) - [Oregon](https://isitonrecall.com/state/oregon/) - [Pennsylvania](https://isitonrecall.com/state/pennsylvania/) - [Rhode Island](https://isitonrecall.com/state/rhode-island/) - [South Carolina](https://isitonrecall.com/state/south-carolina/) - [South Dakota](https://isitonrecall.com/state/south-dakota/) - [Tennessee](https://isitonrecall.com/state/tennessee/) - [Texas](https://isitonrecall.com/state/texas/) - [Utah](https://isitonrecall.com/state/utah/) - [Virginia](https://isitonrecall.com/state/virginia/) - [Vermont](https://isitonrecall.com/state/vermont/) - [Washington](https://isitonrecall.com/state/washington/) - [Wisconsin](https://isitonrecall.com/state/wisconsin/) - [West Virginia](https://isitonrecall.com/state/west-virginia/) - [Wyoming](https://isitonrecall.com/state/wyoming/) ## Dates in the source - **Report date**: Jun 29, 2022 - **Recall initiation date**: Apr 18, 2022 - **Center classification date**: Jun 21, 2022 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. ## What to do next Read the official notice for the action that applies to your exact product. [Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1271-2022%22) ## Related records [Medical devices records](https://isitonrecall.com/category/medical-devices/) [Smiths Medical ASD Inc. records](https://isitonrecall.com/brand/smiths-medical-asd-inc/)