Recall archive / FDA device enforcement

Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d... — FDA record Z-1541-2024

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 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,
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: 7160 pumps
Agency-reported status: Ongoing
Source record identifier: Z-1541-2024

Open the official record

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) 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, 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2027068, 2027069, 2027070, 2027071, 2027...

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) 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, 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The agency lot list is longer than this excerpt. Read the complete list at the official source.

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Distribution

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Dates in the source

Report date: Apr 24, 2024
Recall initiation date: Dec 19, 2023
Center classification date: Apr 15, 2024

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Lot and product identifiers

Distribution

Dates in the source

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