FDAFDA · Alimentos y medicamentos·N.º oficial Z-2341-2024
190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
Publicado el 17 de julio de 2024 · Inicio del retiro: 3 de junio 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
- Domestic: Nationwide Distribution. International: Canada.
- Lote
- Model Number: 190828; UDI/DI: 00840861100941; Serial Numbers: 2K0S179489, 3K0S184885, 3K0S185744, 1K0S172050, 1K0S172202, 1K0S171823, 1K0S172056, 3K0S185989, 3K0S186038, 4K0S190849, 4K0S191132, 1K0S171846, 4K0S192532, 4K0S192534, 4K0S192232, 4K0S191583, 2K0S180629, 3K0S185738, 4K0S190517, 1K0S171488, 1K0S172266, 4K0S192736, 3K0S185730, 3K0S185732, 3K0S185734, 3K0S185740, 3K0S186955, 3K0S187000, 4K0S190509, 4K0S190514, 4K0S190515, 4K0S190519, 4K0S190525, 4K0S190537, 4K0S191511, 4K0S191571, 4K0S191578, 4K0S192514, 4K0S192520, 4K0S192522, 4K0S192523, 4K0S192528, 4K0S192538, 4K0S192235, 4K0S192231, 4K0S192236, 4K0S192237, 2K0S180521, 2K0S180522, 2K0S180527, 3K0S186036, 3K0S182626, 3K0S182627, 3K0S182637, 3K0S182646, 3K0S184910, 3K0S185719, 3K0S185721, 3K0S185739, 3K0S185742, 3K0S186938, 3K0S186951, 3K0S186953, 3K0S186960, 3K0S186995, 3K0S186997, 4K0S190280, 4K0S191586, 4K0S191229, 4K0S191230, 4K0S191232, 4K0S191569, 4K0S191579, 4K0S191580, 4K0S192727, 4K0S192731, 2K0S179494, 2K0S179487, 3K0S182636, 4K0S192226, 4K0S192227, 4K0S192234, 4K0S192239, 4K0S192241, 4K0S192245, 3K0S186032, 3K0S184877, 3K0S184878, 3K0S184895, 3K0S185724, 3K0S185736, 3K0S186042, 3K0S186935, 3K0S186990, 4K0S190518, 4K0S190524, 4K0S191584, 4K0S192242, 4K0S192737, 3K0S182658, 4K0S191129, 4K0S191133, 4K0S192537, 4K0S192230, 2K0S180524, 2K0S180526, 3K0S185720, 2K0S180530, 2K0S180542, 4K0S190538, 4K0S191124, 3K0S184906, 4K0S191233, 3K0S185978, 3K0S186944, 2K0S181716, 3K0S182642, 3K0S185975, 2K0S180516, 3K0S186993, 2K0S179479, 2K0S180529, 2K0S180533, 2K0S179490, 3K0S182656, 3K0S184887, 3K0S182645, 3K0S182655, 2K0S179482, 2K0S179477, 3K0S182635, 3K0S185997, 3K0S186948, 3K0S184893, 4K0S191234, 1K0S172200, 2K0S179485, 1K0S171809, 4K0S191582, 1K0S171481, 3K0S182650, 3K0S186992, 3K0S182654, 3K0S185981, 3K0S186044, 1K0S172057, 4K0S191512, 3K0S185729, 3K0S185979, 3K0S182641, 3K0S182643, 3K0S184890, 4K0S192526, 4K0S192533, 4K0S192729, 4K0S192735, 1K0S171848, 1K0S172052, 3K0S185735, 3K0S184884, 3K0S184892, 1K0S171482, 4K0S191136, 4K0S191122, 4K0S191125, 4K0S191134, 4K0S191123, 4K0S191141, 4K0S192243, 4K0S192244, 4K0S192540, 4K0S190531, 3K0S184891, 3K0S185723, 3K0S185745, 3K0S185988, 3K0S186956, 3K0S187002, 1K0S171808, 4K0S190513, 3K0S185718, 4K0S190511, 4K0S190530, 3K0S182625, 2K0S181709, 2K0S181711, 3K0S186034, 3K0S186998, 3K0S186942, 1K0S172061, 1K0S171825, 1K0S171841, 1K0S171483, 1K0S171815, 2K0S179500, 2K0S181717, 3K0S186950, 3K0S185998, 3K0S184899, 4K0S192730, 4K0S190533, 3K0S185741, 3K0S186962, 4K0S190516, 3K0S185737, 3K0S185728, 4K0S192240, 4K0S192233, 3K0S185310, 2K0S180512, 2K0S180543, 4K0S190846, 3K0S185743, 1K0S172045, 3K0S184879, 3K0S184881, 3K0S184905, 3K0S186933, 2K0S179499, 2K0S179501, 2K0S181719, 3K0S187001, 3K0S186947, 3K0S185994, 3K0S185983, 1K0S172189, 3K0S184907, 3K0S185311, 3K0S184868, 3K0S186989, 3K0S186941, 4K0S192517, 1K0S171818, 4K0S191581, 1K0S171477, 1K0S171498, 2K0S181705, 4K0S192228, 1K0S171839, 1K0S171843, 3K0S186039, 4K0S191139, 4K0S191588, 1K0S171822, 1K0S171829, 2K0S181715, 3K0S182633, 3K0S182638, 3K0S186037, 4K0S190520, 2K0S180525, 2K0S180518, 3K0S185974, 1K0S171479, 3K0S184902, 1K0S171494, 3K0S184865, 3K0S184867, 3K0S184875, 3K0S184889, 3K0S185977, 3K0S185987, 3K0S185996, 3K0S182648, 2K0S181706, 1K0S172042, 3K0S185726, 3K0S186958, 4K0S192536, 3K0S185716, 4K0S192512, 4K0S192728, 1K0S171838, 2K0S181710, 3K0S185992, 4K0S190527, 4K0S190541, 2K0S180546, 3K0S186954, 3K0S182647, 3K0S184874, 3K0S185283, 4K0S190532, 4K0S190534, 3K0S182659, 1K0S171811, 1K0S171832, 1K0S171844, 3K0S186996, 3K0S186999, 3K0S185725, 3K0S185727, 3K0S185982, 4K0S190844, 4K0S190526, 4K0S191570, 1K0S171492, 3K0S186952, 1K0S171491, 3K0S182634, 2K0S181708, 3K0S186991, 3K0S186040, 3K0S185717, 1K0S172192, 2K0S179495, 3K0S182644, 4K0S190539, 4K0S190845, 4K0S190847, 4K0S192527, 1K0S172049, 3K0S182632, 3K0S182651, 3K0S186041, 2K0S179496, 3K0S186939, 4K0S192734, 3K0S185995, 4K0S191140, 3K0S184911, 1K0S172182, 4K0S191131, 4K0S191135, 2K0S181713, 4K0S191130, 3K0S184908, 4K0S192229, 4K
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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