2008T BlueStar Hemodialysis Machine, Model 191124 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.

Detalles del retiro

Fabricante

Fresenius Medical Care Holdings, Inc.

Distribuidor

US Nationwide distribution.

Lote

Component: Model Number: F40015481 Rev A, UDI/DI: N/A, All Rev A lots. Finished Devices: Model Number: 191124, UDI/DI: 00840861102082; Serial Numbers: 0T0S252551, 0T0S252801, 0T0S252806, 1T0S255908, 1T0S256180, 0T0S251792, 0T0S251809, 0T0S251811, 0T0S252810, 0T0S251585, 0T0S251883, 0T0S251899, 1T0S256179, 1T0S256183, 1T0S256184, 1T0S256185, 1T0S256188, 1T0S256190, 1T0S256192, 1T0S256193, 1T0S256197, 1T0S256213, 1T0S256219, 1T0S256220, 1T0S256233, 1T0S256249, 1T0S256255, 1T0S256256, 1T0S256262, 1T0S256278, 1T0S256281, 1T0S256282, 1T0S256286, 2T0S264834, 2T0S264839, 2T0S264852, 2T0S264856, 3T0S272211, 3T0S274176, 3T0S274177, 3T0S274178, 3T0S274183, 3T0S274187, 3T0S274189, 3T0S274190, 3T0S274192, 3T0S274194, 3T0S274195, 3T0S274197, 3T0S274202, 3T0S274204, 3T0S274205, 3T0S274207, 3T0S274209, 1T0S255921, 1T0S255924, 1T0S255936, 1T0S255937, 0T0S252151, 0T0S252175, 0T0S252538, 0T0S252542, 0T0S252554, 0T0S252843, 1T0S255902, 1T0S255904, 1T0S255913, 1T0S255914, 1T0S255915, 1T0S255928, 1T0S255929, 1T0S255930, 1T0S255933, 0T0S251304, 0T0S251902, 0T0S251905, 0T0S251574, 0T0S251616, 0T0S251844, 0T0S251846, 0T0S251856, 0T0S252102, 0T0S252107, 0T0S252124, 0T0S252128, 0T0S252132, 0T0S252143, 0T0S252150, 0T0S252529, 0T0S251885, 0T0S251916, 0T0S251920, 0T0S251929, 0T0S252091, 0T0S252097, 0T0S252100, 0T0S252121, 0T0S252131, 0T0S252136, 0T0S252139, 0T0S252161, 0T0S252163, 1T0S256205, 1T0S256222, 1T0S256225, 1T0S256229, 1T0S256245, 1T0S256266, 1T0S255987, 1T0S255993, 1T0S255998, 1T0S255999, 1T0S256000, 1T0S256001, 1T0S256003, 1T0S256004, 1T0S256007, 1T0S256008, 1T0S256010, 1T0S256012, 0T0S251879, 0T0S251191, 0T0S251487, 0T0S251514, 0T0S251522, 3T0S272205, 3T0S272206, 3T0S272207, 3T0S272208, 3T0S272209, 3T0S272212, 3T0S272213, 3T0S272214, 3T0S272215, 3T0S272216, 3T0S272217, 3T0S272218, 3T0S272219, 3T0S272220, 3T0S272221, 3T0S272222, 3T0S272223, 3T0S272224, 3T0S272507, 3T0S274182, 3T0S274184, 3T0S274185, 3T0S274186, 3T0S274191, 3T0S274193, 3T0S274201, 3T0S274203, 3T0S274208, 0T0S251805, 0T0S251849, 0T0S251864, 0T0S251880, 0T0S251887, 0T0S251893, 0T0S251897, 0T0S251898, 0T0S251907, 0T0S251911, 0T0S251912, 0T0S251914, 0T0S251918, 0T0S251921, 0T0S251928, 0T0S251935, 0T0S252090, 0T0S252094, 0T0S252095, 0T0S252096, 0T0S252103, 0T0S252105, 0T0S252106, 0T0S252110, 0T0S252112, 0T0S252116, 0T0S252119, 0T0S252120, 0T0S252126, 0T0S252133, 0T0S252135, 0T0S252138, 0T0S252145, 0T0S252146, 0T0S252154, 0T0S252155, 0T0S252159, 0T0S252162, 0T0S252167, 0T0S252168, 0T0S251307, 0T0S252537, 0T0S252577, 0T0S252578, 0T0S252792, 0T0S252793, 0T0S252794, 0T0S252798, 0T0S252799, 0T0S252800, 0T0S252804, 0T0S252805, 0T0S252807, 0T0S252808, 0T0S252809, 0T0S252818, 0T0S252819, 0T0S252821, 0T0S252822, 0T0S252831, 1T0S256212, 0T0S251797, 0T0S251843, 0T0S251867, 0T0S251872, 0T0S252166, 0T0S252544, 0T0S252546, 2T0S267998, 3T0S274626, 3T0S274627, 3T0S274631, 3T0S274633, 3T0S274635, 3T0S274637, 3T0S274638, 3T0S274639, 3T0S274640, 3T0S274642, 3T0S274646, 3T0S274647, 3T0S274650, 3T0S274652, 3T0S274657, 3T0S274660, 0T0S251821, 0T0S251875, 0T0S251876, 0T0S251886, 0T0S251551, 0T0S251590, 0T0S251784, 0T0S251839, 0T0S251847, 0T0S251866, 0T0S251874, 0T0S251878, 0T0S251881, 0T0S251889, 0T0S251901, 0T0S251903, 0T0S251906, 3T0S270970, 3T0S270972, 3T0S270974, 3T0S270980, 3T0S272210, 3T0S272492, 3T0S272493, 3T0S272500, 3T0S274175, 3T0S274180, 0T0S251817, 1T0S256176, 1T0S256207, 1T0S256228, 0T0S252795, 0T0S252811, 0T0S252813, 1T0S256215, 0T0S251503, 0T0S251511, 0T0S251608, 0T0S251873, 0T0S251888, 0T0S251892, 0T0S251915, 0T0S251917, 0T0S251919, 0T0S251923, 0T0S251924, 0T0S251925, 0T0S251926, 0T0S251930, 0T0S251931, 0T0S251933, 0T0S251934, 0T0S251936, 0T0S252534, 0T0S252545, 0T0S252828, 1T0S255923, 1T0S255925, 1T0S255938, 1T0S255939, 1T0S255940, 1T0S255942, 1T0S255943, 1T0S255944, 1T0S255945, 1T0S255946, 1T0S255948, 1T0S255974, 1T0S255990, 1T0S256002, 1T0S256005, 1T0S256006, 2T0S264826, 2T0S264828, 2T0S264829, 2T0S264832, 2T0S264837, 2T0S264845, 2T0S264848, 2T0S264849, 2T0S264889, 3T0S272490, 3T0S27249

Clasificación de riesgo

Class II

Área (FDA)

device

País

United States