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.
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. Distribution: Worldwide distribution. Quantity: 7160 pumps Lot/code info: 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 Num
10610586040078, 10610586040054, 10610586040818, 10610586043581, 10610586043567, 10610586043574, 15019517070750, 15019517069624
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.