FDA Enforcement Class I Terminated

Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient care needs.

Recall: Z-0610-2020 · Reported December 18, 2019

Enforcement

Recall Number
Z-0610-2020
Event ID
84232
Classification
Class I
Status
Terminated
Product Type
Devices
Firm
Smiths Medical ASD Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Initial Notification
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Report Date
December 18, 2019
Initiation Date
October 28, 2019
Classification Date
December 12, 2019
Termination Date
June 6, 2024
Address
6000 Nathan Ln N, N/A, Minneapolis, MN, 55442-1690, United States

Description

Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient care needs.

Reason

There is an anomaly in Medfusion 4000 Syringe Pump Firmware version 1.7.0 that could potentially result in loss of primary audible and visual battery alarm functionality, and interruption of therapy.

Code Info

Serial numbers: 2039045, 2039062, 2039082, 2039084, 2039093, 2039122, 2039128, 2039132, 2039133, 2039137, 2039145, 2039151, 2039153, 2039158, 2039164, 2039174, 2039178, 2039181, 2039182, 2039183, 2039187, 2039202, 2039203, 2039204, 2039208, 2039209, 2039210, 2039211, 2039212, 2039216, 2039217, 2039220, 2039221, 2039223, 2039225, 2039226, 2039228, 2039231, 2039232, 2039234, 2039235, 2039236, 2039238, 2039239, 2039246, 2039247, 2039248, 2039250, 2039252, 2039259, 2039290, 2039291, 2039292, 2039295, 2039305, 2039307, 2039308, 2039312, 2039313, 2039315, 2039317, 2039323, 2039325, 2039360, 2039373, 2039394, 2039407, 2039416, 2039419, 2039420, 2039422, 2039435, 2039437, 2039446, 2039453, 2039456, 2039460, 2039461, 2039462, 2039463, 2039464, 2039465, 2039466, 2039469, 2039473, 2039478, 2039483, 2039485, 2039487, 2039490, 2039494, 2039502, 2039503, 2039516, 2039517, 2039545, 2039551, 2039904, 2039910, 2039970, 2040014, 2040029, 2040034, 2040040, 2040047, 2040050, 2040054, 2040068, 2040074, 2040082, 2040091, 2040107, 2040108, 2040140, 2040159, 2040173, 2040191, 2040201, 2040203, 2040205, 2040206, 2040228, 2040231, 2040238, 2040241, 2040255, 2040260, 2040261, 2040271, 2040273, 2040322, 2040323, 2040336, 2040340, 2040383, 2040387, 2040388, 2040390, 2040392, 2040406, 2040411, 2040414, 2040421, 2040422, 2040425, 2040426, 2040432, 2040433, 2040435, 2040437, 2040438, 2040439, 2040441, 2040474, 2040587, 2040601, 2040603, 2040606, 2040610, 2040613, 2040623, 2040663, 2040680, 2040684, 2040699, 2040704, 2040713, 2040715, 2040716, 2040717, 2040718, 2040720, 2040721, 2040722, 2040723, 2040724, 2040726, 2040727, 2040729, 2040730, 2040731, 2040732, 2040733, 2040735, 2040736, 2040737, 2040738, 2040739, 2040740, 2040743, 2040744, 2040746, 2040747, 2040752, 2040757, 2040762, 2040765, 2040773, 2040774, 2040775, 2040776, 2040777, 2040782, 2040786, 2040791, 2040799, 2040802, 2040803, 2040804, 2040805, 2040806, 2040808, 2040809, 2040810, 2040812, 2040813, 2040815, 2040817, 2040818, 2040823, 2040824, 2040832, 2040833, 2040839, 2040872, 2040873, 2040888, 2040889, 2040890, 2040891, 2040902, 2040913, 2040917, 2040935, 2040939, 2040941, 2040942, 2040943, 2040952, 2040953, 2040954, 2040955, 2040958, 2040959, 2040976, 2040987, 2040992, 2040997, 2041033, 2041176, 2041177, 2041183, 2041187, 2041190, 2041191, 2041192, 2041195, 2041198, 2041199, 2041200, 2041201, 2041202, 2041204, 2041205, 2041206, 2041207, 2041209, 2041211, 2041212, 2041214, 2041215, 2041216, 2041217, 2041218, 2041222, 2041224, 2041225, 2041226, 2041229, 2041230, 2041231, 2041234, 2041235, 2041236, 2041237, 2041238, 2041239, 2041241, 2041242, 2041243, 2041244, 2041245, 2041247, 2041248, 2041250, 2041251, 2041252, 2041253, 2041254, 2041255, 2041256, 2041258, 2041259, 2041260, 2041261, 2041262, 2041263, 2041264, 2041265, 2041266, 2041268, 2041269, 2041270, 2041271, 2041272, 2041273, 2041274, 2041275, 2041276, 2041279, 2041280, 2041281, 2041283, 2041284, 2041285, 2041287, 2041288, 2041290, 2041291, 2041292, 2041293, 2041294, 2041296, 2041297, 2041299, 2041301, 2041302, 2041303, 2041306, 2041307, 2041309, 2041310, 2041311, 2041312, 2041315, 2041316, 2041318, 2041319, 2041320, 2041321, 2041322, 2041324, 2041326, 2041328, 2041330, 2041331, 2041332, 2041333, 2041334, 2041336, 2041338, 2041339, 2041340, 2041341, 2041342, 2041343, 2041344, 2041345, 2041346, 2041348, 2041350, 2041351, 2041353, 2041354, 2041356, 2041358, 2041359, 2041360, 2041361, 2041362, 2041364, 2041366, 2041367, 2041369, 2041370, 2041372, 2041373, 2041374, 2041375, 2041376, 2041377, 2041379, 2041380, 2041382, 2041383, 2041384, 2041386, 2041387, 2041388, 2041389, 2041390, 2041393, 2041394, 2041395, 2041396, 2041398, 2041401, 2041402, 2041405, 2041406, 2041407, 2041409, 2041410, 2041412, 2041413, 2041414, 2041416, 2041417, 2041418, 2041419, 2041420, 2041421, 2041422, 2041423, 2041424, 2041426, 2042293, 2042482, 2042483, 2042484, 2042486, 2042487, 2042489, 2042490, 2042491, 2042492, 2042493, 2042495, 2042497, 2042501, 2042505, 2042506, 2042509, 2042513, 2042514, 2042516, 2042518, 2042519, 2042520, 2042521, 2042522, 2042525, 2042526, 2042528, 2042529, 2042531, 2042532, 2042533, 2042535, 2042539, 2042540, 2042546, 2042547, 2042548, 2042550, 2042553, 2042556, 2042561, 2042564, 2042567, 2042568, 2042579, 2042582, 2042584, 2042587, 2042588, 2042589, 2042590, 2042594, 2042600, 2042603, 2042608, 2042609, 2042610, 2042615, 2042617, 2042618, 2042619, 2042622, 2042628, 2042629, 2042630, 2042633, 2042635, 2042639, 2042641, 2042642, 2042643, 2042644, 2042645, 2042646, 2042650, 2042651, 2042652, 2042653, 2042655, 2042666, 2042672, 2042673, 2042676, 2042678, 2042680, 2042682, 2042683, 2042684, 2042685, 2042688, 2042690, 2042692, 2042693, 2042696, 2042698, 2042699, 2042700, 2042703, 2042705, 2042707, 2042709, 2042713, 2042714, 2042715, 2042716, 2042717, 2042720, 2042721, 2042723, 2042724, 2042725, 2042728, 2042729, 2042730, 2042731, 2042732, 2042733, 2042734, 2042736, 2042737, 2042738, 2042739, 2042740, 2042741, 2042742, 2042745, 2042746, 2042747, 2042748, 2042750, 2042753, 2042754, 2042755, 2042756, 2042758, 2042759, 2042760, 2042761, 2042762, 2042763, 2042767, 2042769, 2042770, 2042771, 2042772, 2042774, 2042778, 2042779, 2042780, 2042781, 2042785, 2042787, 2042791, 2042794, 2042795, 2042805, 2042806, 2042807, 2042809, 2042810, 2042815, 2043264, 2043265, 2043266, 2043267, 2043268, 2043269, 2043270, 2046025, 2046026, 2046027, 2046028, 2046029, 2046030, 2046031, 2046032, 2046033, 2046034, 2046035, 2046036, 2046037, 2046038, 2046039, 2046040, 2046041, 2046042, 2046043, 2046044, 2046045, 2046046, 2046047, 2046048, 2046049, 2046050, 2046051, 2046052, 2046053, 2046054, 2046055, 2046056.

Distribution

CO, MD, NY

Quantity

626 devices