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,

Detalles del retiro

Fabricante

Smiths Medical ASD Inc.

Distribuidor

Worldwide distribution.

Lote

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, 2024581, 2024583, 2024664, 2024725, 2024727, 2024731, 2024812, 2024984, 2024985, 2025003, 2025053, 2025054, 2025057, 2025133, 2025144, 2025161, 2025219, 2025220, 2025244, 2025255, 2025270, 2025282, 2025304, 2025550, 2025559, 2025776, 2025799, 2025999, 2026046, 2026047, 2026048, 2026049, 2026050, 2026051, 2026052, 2026053, 2026054, 2026055, 2026056, 2026057, 2026058, 2026059, 2026060, 2026061, 2026062, 2026063, 2026064, 2026065, 2026066, 2026067, 2026068, 2026069, 2026070, 2026071, 2026072, 2026073, 2026074, 2026075, 2026076, 2026077, 2026078, 2026079, 2026080, 2026081, 2026082, 2026083, 2026084, 2026085, 2026086, 2026087, 2026088, 2026089, 2026090, 2026091, 2026092, 2026093, 2026094, 2026095, 2026096, 2026097, 2026098, 2026099, 2026100, 2026101, 2026102, 2026103, 2026104, 2026105, 2026106, 2026107, 2026108, 2026109, 2026110, 2026111, 2026112, 2026113, 2026114, 2026115, 2026116, 2026117, 2026118, 2026119, 2026120, 2026121, 2026122, 2026123, 2026124, 2026125, 2026126, 2026127, 2026128, 2026129, 202613

Clasificación de riesgo

Class II

Área (FDA)

device

País

United States