Class 1 Device Recall Medfusion Model 4000 Pump

• Date Initiated by Firm: October 28, 2019
• Date Posted: December 12, 2019
• Recall Status: Terminated on June 06, 2024
• Recall Number: Z-0610-2020
• Recall Event ID: 84232
• 510(K)Number: K111386
• Product Classification: Pump, infusion - Product Code FRN
• Product: 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.
• Code Information: 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.
• Recalling Firm/ Manufacturer: Smiths Medical ASD Inc.; 6000 Nathan Ln N; Minneapolis MN 55442-1690
• For Additional Information Contact: Dave Halverson; 763-383-3072
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Software design
• Action: An Urgent Medical Device recall letter dated 10/28/2019 was sent to customers via email beginning 10/28/2019. The letter identified affected product, stated the issue, and provided instructions for customers to return the pumps. A response form was asked to be returned. Questions can be directed to fieldactions@smiths-medical.com.
• Quantity in Commerce: 626 devices
• Distribution: CO, MD, NY
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = FRN