FDAFDA · Alimentos y medicamentos·N.º oficial Z-1870-2024
2008T BlueStar Hemodialysis Machine, Model 191130 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A
Publicado el 29 de mayo de 2024 · Inicio del retiro: 17 de abril de 2024
Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
Qué hacer
Voluntary: Firm initiated · Letter
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: 191130, UDI/DI: 00840861102112; Serial Numbers: 2T0S265095, 2T0S265131, 2T0S266383, 2T0S266406, 2T0S266459, 0T0S251328, 0T0S251333, 0T0S251334, 0T0S251335, 0T0S251337, 0T0S251338, 0T0S251343, 0T0S251345, 0T0S251347, 0T0S251348, 0T0S251349, 0T0S251354, 0T0S251363, 0T0S251365, 0T0S251368, 0T0S251370, 0T0S251375, 0T0S251385, 0T0S251401, 0T0S251413, 0T0S251419, 0T0S254338, 0T0S254385, 0T0S252442, 0T0S252451, 0T0S252453, 2T0S268393, 3T0S273665, 0T0S254884, 0T0S254888, 0T0S254893, 4T0S277762, 4T0S277765, 4T0S277775, 4T0S277785, 4T0S277787, 4T0S277791, 4T0S277793, 4T0S277795, 4T0S277800, 4T0S277801, 4T0S277802, 4T0S277806, 4T0S277807, 4T0S277808, 4T0S277812, 4T0S277817, 4T0S277818, 4T0S277821, 4T0S277822, 4T0S277831, 4T0S277860, 4T0S277869, 3T0S270989, 3T0S270996, 3T0S271096, 3T0S271365, 3T0S271366, 3T0S271368, 3T0S271370, 3T0S271372, 3T0S271374, 3T0S271375, 3T0S271386, 3T0S271388, 3T0S271391, 3T0S271405, 3T0S271408, 3T0S271412, 3T0S271423, 3T0S271461, 3T0S271473, 3T0S271474, 3T0S271476, 3T0S271489, 3T0S271490, 3T0S271513, 3T0S271525, 3T0S271533, 1T0S257450, 1T0S257451, 1T0S257452, 1T0S257453, 1T0S257456, 1T0S257458, 1T0S257459, 1T0S257460, 1T0S257461, 1T0S257462, 1T0S257463, 1T0S257464, 1T0S257476, 1T0S257484, 1T0S257493, 1T0S257533, 1T0S257558, 1T0S257562, 1T0S257570, 1T0S257579, 1T0S257583, 1T0S257618, 1T0S257630, 1T0S257648, 1T0S257654, 0T0S251455, 0T0S251464, 0T0S251474, 0T0S251475, 0T0S251480, 2T0S264058, 2T0S264081, 0T0S254168, 0T0S254172, 0T0S254181, 0T0S254193, 0T0S254194, 0T0S254196, 0T0S254200, 0T0S254201, 0T0S254202, 0T0S254203, 0T0S254204, 0T0S254205, 0T0S254208, 0T0S254209, 0T0S254211, 0T0S254212, 0T0S254217, 0T0S254220, 0T0S254234, 1T0S258327, 1T0S258349, 1T0S258356, 1T0S258669, 1T0S258670, 1T0S258672, 1T0S258673, 1T0S258675, 1T0S258679, 1T0S258686, 1T0S258695, 1T0S258699, 1T0S258708, 1T0S258717, 1T0S258722, 1T0S258730, 1T0S260300, 1T0S260303, 1T0S260304, 1T0S260307, 1T0S260319, 1T0S260326, 1T0S260327, 1T0S260329, 1T0S260360, 2T0S263247, 2T0S263248, 2T0S263249, 2T0S263252, 2T0S263253, 2T0S263255, 2T0S263256, 2T0S263260, 2T0S263266, 2T0S263268, 2T0S263269, 2T0S263270, 2T0S263272, 2T0S263273, 2T0S263274, 2T0S263276, 2T0S263288, 2T0S263292, 2T0S265631, 2T0S265663, 2T0S265682, 2T0S265774, 2T0S265784, 2T0S265813, 2T0S265815, 2T0S265822, 2T0S265836, 2T0S265850, 2T0S265858, 2T0S266705, 2T0S266753, 2T0S266763, 2T0S266766, 2T0S266777, 2T0S266786, 2T0S266787, 2T0S266788, 2T0S266792, 2T0S266799, 2T0S266801, 2T0S266806, 3T0S273721, 3T0S274323, 3T0S274335, 3T0S274360, 2T0S265633, 2T0S265639, 2T0S265651, 2T0S265658, 2T0S265687, 2T0S265698, 2T0S265724, 2T0S265739, 2T0S265754, 2T0S265804, 2T0S265842, 2T0S265845, 2T0S265846, 2T0S267321, 3T0S270185, 3T0S270901, 3T0S270909, 3T0S270920, 3T0S270926, 3T0S270934, 3T0S270935, 3T0S270937, 3T0S270938, 3T0S270941, 3T0S270943, 3T0S270945, 3T0S270947, 3T0S270960, 2T0S263676, 2T0S263679, 2T0S263688, 2T0S268146, 2T0S268178, 2T0S268181, 2T0S268187, 2T0S268190, 2T0S268195, 2T0S268207, 2T0S268214, 2T0S268232, 2T0S268237, 2T0S268238, 2T0S268240, 2T0S268247, 2T0S268248, 2T0S268251, 2T0S268252, 2T0S268255, 2T0S268257, 2T0S268265, 2T0S268267, 2T0S268275, 2T0S268279, 2T0S268284, 2T0S268288, 2T0S268300, 2T0S268304, 2T0S268308, 2T0S268310, 4T0S275335, 4T0S275356, 4T0S275388, 4T0S275412, 4T0S275414, 4T0S275418, 4T0S275420, 4T0S275424, 4T0S275425, 4T0S275430, 4T0S275431, 4T0S275436, 4T0S275439, 4T0S275448, 4T0S275449, 4T0S275454, 4T0S275458, 4T0S275469, 4T0S275474, 4T0S275487, 4T0S275491, 4T0S275990, 4T0S275994, 4T0S276006, 4T0S276009, 4T0S276010, 4T0S276017, 4T0S276018, 4T0S276020, 4T0S276024, 4T0S276028, 4T0S276030, 4T0S276031, 4T0S276032, 4T0S276033, 4T0S276036, 4T0S276037, 4T0S276044, 4T0S276047, 4T0S276055, 4T0S276057, 3T0S268864, 3T0S268909, 3T0S268940, 3T0S268952, 3T0S268953, 3T0S268957, 3T0S268966, 3T0S268980, 3T0S268985, 3T0S268986, 3T0S268989, 3T0S268990, 3T0S268991, 3T0S268992, 3T0S268994, 3T0S26899
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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