2008T BlueStar Hemodialysis Machine, Model 191126 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: 191126, UDI/DI: 00840861102099; Serial Numbers: 3T0S270687, 3T0S270700, 3T0S274007, 3T0S274009, 3T0S274011, 3T0S274012, 3T0S274016, 3T0S274057, 3T0S274859, 3T0S274920, 3T0S274922, 3T0S274923, 3T0S274938, 3T0S274957, 3T0S274969, 3T0S274970, 3T0S274980, 3T0S274985, 3T0S274996, 3T0S274997, 3T0S275004, 3T0S275009, 3T0S275011, 1T0S262226, 1T0S262249, 1T0S262254, 1T0S262257, 1T0S262265, 1T0S262266, 1T0S262267, 1T0S262268, 1T0S262269, 1T0S262272, 1T0S262273, 1T0S262274, 1T0S262275, 1T0S262276, 1T0S262278, 1T0S262279, 1T0S262280, 1T0S262282, 1T0S262283, 1T0S262284, 1T0S262285, 1T0S262286, 1T0S262289, 1T0S262293, 1T0S262294, 1T0S262296, 1T0S262297, 1T0S262299, 1T0S262300, 1T0S262305, 1T0S262313, 1T0S262315, 1T0S262319, 1T0S262321, 4T0S275623, 4T0S275627, 4T0S275628, 4T0S275629, 4T0S275639, 4T0S275649, 4T0S275654, 4T0S275662, 4T0S275664, 4T0S275666, 4T0S275677, 4T0S275682, 4T0S275685, 4T0S275688, 4T0S275692, 4T0S275703, 4T0S275729, 4T0S275738, 4T0S275742, 4T0S275745, 4T0S275760, 4T0S275768, 4T0S275769, 4T0S275778, 4T0S275787, 4T0S275800, 4T0S275804, 4T0S276804, 4T0S276814, 4T0S276818, 4T0S276829, 4T0S276833, 4T0S276838, 4T0S276858, 4T0S276867, 4T0S276870, 3T0S269793, 3T0S269826, 3T0S269827, 3T0S269828, 3T0S269836, 3T0S269838, 3T0S269841, 3T0S269842, 3T0S269954, 3T0S269955, 3T0S269956, 3T0S269957, 3T0S269959, 3T0S269960, 3T0S269961, 3T0S269963, 3T0S269964, 3T0S269965, 3T0S269966, 3T0S269968, 3T0S269972, 3T0S269976, 3T0S269978, 3T0S269979, 0T0S253172, 0T0S253178, 0T0S253179, 0T0S253184, 0T0S253188, 0T0S253190, 0T0S253203, 0T0S253208, 0T0S253215, 0T0S253217, 0T0S253222, 0T0S253223, 0T0S253227, 0T0S253230, 0T0S253231, 0T0S253232, 0T0S253240, 0T0S253245, 0T0S253257, 0T0S253268, 0T0S253271, 0T0S253272, 0T0S253286, 1T0S260028, 1T0S260091, 1T0S261521, 1T0S261526, 1T0S261527, 1T0S261536, 1T0S261556, 1T0S261557, 1T0S261558, 1T0S261559, 1T0S261572, 1T0S261573, 1T0S261578, 1T0S261581, 1T0S261588, 1T0S261747, 1T0S261771, 1T0S261776, 1T0S261787, 1T0S261788, 1T0S261790, 1T0S261792, 1T0S261794, 1T0S261810, 1T0S261812, 1T0S261821, 1T0S261836, 4T0S276807, 4T0S276886, 4T0S276894, 4T0S276895, 4T0S276897, 4T0S276909, 4T0S276911, 4T0S276912, 4T0S276916, 4T0S276921, 4T0S276926, 4T0S276928, 4T0S276934, 4T0S276952, 4T0S276960, 4T0S276961, 4T0S276963, 4T0S276964, 4T0S276965, 4T0S276969, 4T0S276973, 4T0S276976, 4T0S276979, 4T0S276991, 4T0S276998, 4T0S276999, 4T0S277004, 4T0S277005, 1T0S257039, 1T0S257061, 1T0S257078, 1T0S257083, 1T0S257089, 1T0S257097, 1T0S257107, 1T0S257115, 1T0S257116, 1T0S257129, 1T0S257138, 1T0S257141, 1T0S257153, 1T0S257156, 1T0S257157, 1T0S257161, 1T0S257163, 1T0S257166, 1T0S257171, 1T0S257173, 1T0S257178, 1T0S257194, 1T0S262433, 1T0S261874, 1T0S261934, 1T0S261946, 1T0S262256, 1T0S262271, 1T0S262301, 3T0S268718, 3T0S268750, 3T0S269695, 3T0S269702, 3T0S269709, 3T0S269710, 3T0S269712, 3T0S269713, 0T0S252683, 0T0S252712, 0T0S252742, 0T0S253194, 0T0S253220, 0T0S253356, 0T0S253372, 0T0S253393, 0T0S253400, 0T0S253408, 0T0S253416, 0T0S253423, 0T0S253427, 0T0S253616, 0T0S253632, 0T0S253636, 0T0S253638, 0T0S253646, 0T0S253647, 0T0S253649, 0T0S253678, 0T0S253962, 1T0S258819, 1T0S258845, 1T0S258873, 1T0S258891, 1T0S259185, 1T0S259188, 1T0S259360, 1T0S259362, 1T0S259369, 1T0S259373, 1T0S259377, 1T0S259400, 1T0S259403, 1T0S260106, 1T0S260120, 1T0S260122, 1T0S260125, 1T0S260128, 1T0S260131, 1T0S260135, 1T0S260136, 1T0S260141, 1T0S257132, 1T0S257162, 1T0S257183, 0T0S253221, 0T0S253235, 0T0S253274, 0T0S253296, 0T0S253298, 0T0S253299, 0T0S253378, 0T0S253384, 0T0S253394, 0T0S253411, 0T0S253431, 0T0S253435, 0T0S253441, 0T0S253443, 0T0S253445, 0T0S253449, 0T0S253453, 0T0S253454, 0T0S253455, 0T0S253463, 0T0S253466, 0T0S253467, 0T0S253469, 0T0S253470, 0T0S253471, 0T0S253472, 0T0S253474, 0T0S253475, 0T0S253483, 0T0S253484, 0T0S253485, 0T0S253486, 0T0S253488, 0T0S253491, 0T0S253492, 0T0S253494, 0T0S253501, 0T0S253503, 0T0S255162, 0T0S255178, 1T0S261828, 1T0S26185

Clasificación de riesgo

Class II

Área (FDA)

device

País

United States