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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94775

8 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
June 03, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Fresenius Medical Care Holdings, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

8 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 8

190904 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev A

Z-2340-2024
Recall number
Z-2340-2024
Initiated
June 03, 2024
Classification
Class II
Status
Ongoing
Quantity
372 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Model Number: 190904; UDI/DI: 00840861100965; Serial Numbers: 5K0S194173, 7K0S300085, 4K0S190310, 4K0S190311, 4K0S190312, 4K0S190314, 4K0S190315, 4K0S190318, 4K0S190321, 4K0S192510, 4K0S192511, 4K0S192812, 4K0S192813, 4K0S192814, 4K0S192815, 4K0S192816, 4K0S192817, 4K0S192818, 4K0S192819, 4K0S192820, 4K0S192821, 4K0S192822, 4K0S192823, 4K0S192824, 4K0S192825, 4K0S192826, 4K0S192827, 4K0S192828, 4K0S192829, 4K0S192830, 4K0S192831, 4K0S192832, 5K0S194166, 5K0S194176, 6K0S172023, 7K0S300011, 7K0S300034, 6K0S172010, 7K0S300092, 7K0S300105, 7K0S300067, 7K0S300074, 7K0S300069, 6K0S172008, 5K0S194162, 6K0S163684, 6K0S172021, 7K0S300019, 7K0S300062, 7K0S300016, 7K0S300027, 6K0S171203, 6K0S169446, 6K0S159427, 6K0S167051, 5K0S193166, 5K0S194156, 6K0S167044, 6K0S167045, 6K0S167049, 6K0S159417, 6K0S165409, 5K0S194145, 6K0S169433, 5K0S193324, 5K0S193676, 6K0S165407, 5K0S193147, 5K0S193677, 6K0S171200, 6K0S167035, 5K0S193312, 6K0S159423, 6K0S159430, 6K0S165412, 6K0S169448, 6K0S172019, 7K0S300009, 7K0S300012, 7K0S300006, 7K0S300007, 7K0S300013, 7K0S300025, 6K0S169442, 5K0S193318, 6K0S162829, 6K0S163670, 6K0S171205, 5K0S194159, 5K0S194169, 5K0S194167, 5K0S194172, 6K0S172022, 5K0S194178, 5K0S193319, 7K0S300040, 6K0S172001, 7K0S300044, 7K0S300060, 5K0S193161, 5K0S193162, 5K0S193165, 5K0S193167, 5K0S193146, 5K0S193151, 5K0S193159, 5K0S193313, 5K0S193332, 5K0S193314, 5K0S193317, 5K0S193326, 5K0S193678, 6K0S162830, 6K0S162834, 6K0S162837, 6K0S162842, 6K0S162844, 6K0S162840, 6K0S162845, 7K0S300032, 7K0S300031, 7K0S300059, 7K0S300017, 7K0S300066, 6K0S163669, 5K0S193667, 5K0S193669, 5K0S193670, 5K0S193672, 5K0S193674, 5K0S193675, 5K0S194147, 5K0S194152, 5K0S194154, 5K0S194177, 6K0S169444, 6K0S172007, 6K0S165410, 6K0S167031, 6K0S171195, 6K0S171197, 6K0S171209, 5K0S194180, 7K0S300024, 5K0S193169, 6K0S169447, 6K0S169440, 6K0S172012, 6K0S172017, 6K0S159418, 6K0S169462, 6K0S167042, 7K0S300053, 6K0S167040, 6K0S167041, 4K0S190313, 5K0S194158, 6K0S171201, 6K0S169436, 5K0S193315, 7K0S300014, 6K0S162835, 6K0S162836, 6K0S167034, 6K0S167052, 7K0S300091, 6K0S159428, 5K0S194153, 5K0S193336, 6K0S169438, 6K0S169450, 7K0S300043, 5K0S194160, 7K0S300071, 7K0S300005, 6K0S172011, 6K0S169452, 6K0S172005, 5K0S193144, 7K0S300058, 5K0S193328, 6K0S159421, 5K0S194163, 6K0S169449, 6K0S169453, 6K0S171204, 7K0S300010, 7K0S300089, 6K0S163668, 6K0S159424, 6K0S159431, 6K0S167037, 5K0S193665, 7K0S300028, 5K0S193160, 6K0S167039, 7K0S300093, 7K0S300095, 6K0S163674, 7K0S300022, 5K0S193163, 5K0S194148, 6K0S172018, 6K0S165414, 6K0S163672, 6K0S163681, 6K0S163676, 6K0S163680, 6K0S169437, 7K0S300035, 5K0S193152, 6K0S159420, 6K0S169439, 6K0S169464, 6K0S171198, 6K0S171206, 6K0S171999, 6K0S172016, 6K0S172020, 6K0S169457, 6K0S172002, 6K0S172013, 6K0S162833, 6K0S165411, 6K0S165413, 7K0S300102, 7K0S300033, 5K0S194150, 6K0S162832, 6K0S169445, 5K0S193168, 5K0S194149, 6K0S163682, 6K0S162839, 6K0S167047, 6K0S171196, 5K0S194157, 5K0S193334, 7K0S300103, 6K0S169434, 6K0S162831, 6K0S163673, 6K0S172014, 6K0S163675, 6K0S163685, 7K0S300021, 6K0S163666, 5K0S193154, 5K0S193325, 6K0S165408, 5K0S193143, 5K0S193158, 5K0S194168, 7K0S300078, 5K0S193149, 5K0S193157, 5K0S193170, 7K0S300030, 5K0S193323, 5K0S193331, 7K0S300107, 6K0S159419, 6K0S159426, 6K0S169456, 7K0S300087, 7K0S300075, 5K0S194151, 6K0S163686, 7K0S300029, 5K0S193156, 5K0S193164, 6K0S169460, 6K0S167043, 6K0S167048, 6K0S167050, 6K0S169465, 7K0S300070, 7K0S300068, 6K0S167053, 6K0S167033, 6K0S167055, 6K0S167032, 5K0S193171, 5K0S193172, 6K0S169443, 6K0S167046, 7K0S300042, 5K0S194171, 4K0S190319, 5K0S193330, 5K0S193153, 5K0S193671, 5K0S194175, 6K0S169466, 6K0S169467, 6K0S171995, 6K0S172003, 6K0S169461, 6K0S171202, 6K0S171210, 6K0S171199, 6K0S171207, 6K0S171211, 6K0S172009, 5K0S193333, 6K0S163667, 6K0S163671, 6K0S172015, 6K0S171996, 6K0S171997, 5K0S193316, 6K0S163679, 6K0S172000, 7K0S300072, 7K0S300100, 7K0S300008, 7K0S300020, 7K0S300026, 6K0S171998, 5K0S193335, 5K0S194165, 6K0S162827, 6K0S162828, 6K0S162838, 6K0S162843, 5K0S193329, 5K0S193148, 5K0S193145, 5K0S193150, 6K0S162841, 5K0S193668, 6K0S159416, 6K0S162846, 6K0S167038, 5K0S194170, 4K0S190309, 5K0S193155, 5K0S193679, 5K0S194155, 6K0S169454, 6K0S169463, 6K0S159422, 6K0S159425, 6K0S169435, 6K0S167054, 6K0S172006, 6K0S172024, 6K0S171208, 6K0S172004, 6K0S169451, 6K0S163678, 7K0S300047, 7K0S300051, 7K0S300054, 7K0S300064, 7K0S300065, 7K0S300076, 7K0S300098, 6K0S169459, 6K0S167036, 6K0S169455, 5K0S193321, 5K0S193666, 5K0S193673, 7K0S300106, 7K0S300104, 6K0S167030, 7K0S300041, 7K0S300050, 7K0S300052, 7K0S300057, 7K0S300090,

Distribution pattern

Domestic: Nationwide Distribution. International: Canada.

device · product 2 of 8

190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model Number: F40015481 Rev A

Z-2341-2024
Recall number
Z-2341-2024
Initiated
June 03, 2024
Classification
Class II
Status
Ongoing
Quantity
531 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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, 4K0S190522, 1K0S172185, 4K0S192530, 2K0S180517, 2K0S180531, 4K0S190852, 4K0S190853, 2K0S179488, 4K0S191231, 3K0S184894, 2K0S179484, 3K0S182652, 3K0S182657, 4K0S192516, 4K0S190543, 1K0S172059, 1K0S172190, 3K0S184872, 3K0S182629, 3K0S185985, 3K0S186946, 4K0S190512, 1K0S172186, 1K0S172188, 1K0S171810, 1K0S171831, 1K0S171828, 1K0S171842, 3K0S185284, 3K0S185309, 3K0S185722, 3K0S184903, 4K0S190850, 3K0S185281, 3K0S186043, 3K0S184864, 1K0S171480, 3K0S182649, 3K0S185984, 4K0S190521, 4K0S190528, 4K0S190535, 4K0S190536, 4K0S190542, 4K0S192519, 4K0S192525, 4K0S192531, 1K0S172043, 1K0S172193, 2K0S179478, 2K0S179481, 4K0S191585, 4K0S192238, 4K0S192515, 4K0S192524, 3K0S182628, 2K0S179497, 3K0S182630, 3K0S186934, 1K0S171485, 3K0S185733, 3K0S186035, 4K0S192732, 3K0S185731, 1K0S171476, 1K0S172051, 3K0S182653, 3K0S182639, 4K0S192724, 4K0S192726, 1K0S171814, 4K0S190523, 4K0S190854, 4K0S190510, 4K0S191126, 4K0S191127, 1K0S171497, 3K0S182631, 1K0S171827, 3K0S184909, 1K0S171824, 1K0S171826, 1K0S171475, 1K0S171499, 2K0S179480, 2K0S179483, 2K0S180513, 2K0S180519, 3K0S186945, 3K0S186957, 3K0S186936, 3K0S186045, 2K0S181707, 2K0S181712, 2K0S181718, 1K0S171487, 3K0S186940, 3K0S186959, 3K0S185986, 3K0S185991, 4K0S190540, 2K0S180520, 2K0S180532, 2K0S180628, 4K0S190851, 4K0S191587, 3K0S185282, 3K0S186031, 2K0S181714, 3K0S184869, 3K0S184871, 3K0S184873, 3K0S184880, 3K0S184900, 3K0S184904, 3K0S184912, 3K0S184866, 3K0S184876, 3K0S184886, 3K0S184888, 3K0S184896, 3K0S184897, 3K0S184898, 3K0S185993, 3K0S186033, 4K0S192513, 4K0S192535, 4K0S191572, 4K0S190529, 1K0S171833, 1K0S171840, 3K0S185308, 1K0S171849, 1K0S172044, 4K0S192725, 4K0S192529, 2K0S180523, 4K0S191137, 3K0S186937, 3K0S186943, 3K0S186994, 1K0S172196, 1K0S172264, 1K0S172265, 1K0S172183, 1K0S172263, 1K0S171837, 1K0S171493, 1K0S172191, 1K0S172201, 1K0S171489, 1K0S171807, 1K0S172054, 1K0S172194, 1K0S172198, 1K0S171820, 1K0S172205, 1K0S171819, 1K0S171830, 1K0S171486, 1K0S171836, 2K0S179486, 2K0S179492, 2K0S179493, 2K0S179498, 1K0S171812, 1K0S171813, 1K0S171821, 1K0S172048, 1K0S172053, 1K0S172060, 1K0S172179, 1K0S172184, 1K0S172204, 1K0S171847, 1K0S172180, 1K0S172203, 1K0S172195, 1K0S172197, 1K0S171816, 1K0S171835, 1K0S172058, 1K0S172187, 1K0S172199, 3K0S184882, 3K0S184901, 3K0S184883, 3K0S185307, 3K0S185976, 4K0S191138, 4K0S190848, 4K0S191128, 4K0S192521, 3K0S182640, 1K0S171817, 3K0S185980, 3K0S186961, 3K0S186949, 4K0S191513, 1K0S171834, 2K0S179491, 4K0S192733, 4K0S192723.

Distribution pattern

Domestic: Nationwide Distribution. International: Canada.

device · product 3 of 8

191014: 2008K@HOME HD SYSTEM W/BIBAG (CANADA) - Blood Pump Rotor spare part, Model Number: F40015481 Rev A

Z-2342-2024
Recall number
Z-2342-2024
Initiated
June 03, 2024
Classification
Class II
Status
Ongoing
Quantity
20 units (all OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Model Number: 191014; UDI/DI: N/A (Canada only); Serial Number: 6K0S162351, 6K0S162352, 6K0S162353, 6K0S162354, 6K0S162355, 6K0S169113, 6K0S169114, 6K0S169115, 6K0S169116, 6K0S169117, 6K0S169118, 6K0S169119, 6K0S169120, 6K0S169121, 6K0S169122, 6K0S169123, 6K0S169124, 6K0S169125, 6K0S169126, 6K0S169127.

Distribution pattern

Domestic: Nationwide Distribution. International: Canada.

device · product 4 of 8

190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A

Z-2343-2024
Recall number
Z-2343-2024
Initiated
June 03, 2024
Classification
Class II
Status
Ongoing
Quantity
1,156 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Model Number: 190395; UDI/DI: 00840861100958; Serial Number: 6K0S-985P, 7K0S107747, 6K0S-021M, 7K0S103530, 6K0S-780R, 6K0S-192E, 6K0S-217E, 7K0S102986, 7K0S110138, 7K0S110142, 7K0S106422, 4K0S-P981, 4K0S-N154, 4K0S-N157, 4K0S-Q697, 5K0S-V190, 5K0S-V199, 6K0S-012R, 4K0S-M705, 4K0S-M708, 4K0S-N842, 4K0S-N843, 4K0S-N846, 4K0S-N850, 4K0S-N913, 4K0S-P289, 4K0S-P290, 4K0S-P298, 4K0S-P299, 4K0S-R079, 4K0S-R106, 4K0S-R114, 4K0S-R082, 4K0S-R136, 4K0S-S707, 4K0S-S708, 4K0S-S716, 6K0S-320H, 6K0S-325H, 6K0S-332H, 4K0S-S713, 5K0S-309C, 4K0S-M703, 4K0S-N847, 4K0S-R080, 4K0S-L722, 4K0S-N152, 4K0S-N155, 4K0S-N159, 4K0S-P291, 4K0S-P294, 4K0S-P295, 4K0S-Q694, 4K0S-Q688, 4K0S-R107, 4K0S-R081, 5K0S-T891, 4K0S-R135, 7K0S106375, 5K0S-168D, 5K0S-Z661, 5K0S-Z668, 4K0S-S711, 5K0S-306C, 5K0S-159D, 5K0S-881D, 6K0S-491J, 6K0S-501F, 6K0S-435N, 7K0S108256, 6K0S-746N, 5K0S-311C, 6K0S-508F, 6K0S-016M, 5K0S-305C, 6K0S-532F, 6K0S-318H, 6K0S-722R, 5K0S-Y002, 6K0S-481K, 6K0S-488K, 6K0S-669L, 4K0S-Q643, 5K0S-Y003, 4K0S-M704, 4K0S-M707, 4K0S-N849, 4K0S-P288, 4K0S-Q641, 4K0S-Q689, 4K0S-Q690, 4K0S-Q691, 4K0S-R109, 4K0S-R113, 4K0S-R134, 4K0S-R137, 4K0S-S704, 5K0S-T897, 5K0S-T898, 5K0S-V200, 5K0S-V201, 5K0S-X989, 5K0S-883D, 6K0S-468G, 6K0S-847G, 6K0S-848G, 6K0S-092L, 6K0S-322L, 6K0S-673L, 6K0S-992P, 6K0S-998P, 4K0S-M706, 4K0S-R083, 4K0S-S712, 4K0S-S722, 5K0S-V191, 5K0S-V204, 5K0S-X987, 5K0S-X990, 5K0S-Z667, 5K0S-466B, 6K0S-219E, 6K0S-482J, 6K0S-835N, 6K0S-778R, 7K0S100621, 7K0S102665, 7K0S103781, 4K0S-S715, 5K0S-V202, 5K0S-885D, 4K0S-N844, 4K0S-P292, 4K0S-S706, 5K0S-T887, 5K0S-T892, 5K0S-Z664, 5K0S-184C, 5K0S-Z654, 5K0S-Z660, 6K0S-437N, 6K0S-834N, 6K0S-015R, 5K0S-160D, 6K0S-815K, 6K0S-022M, 6K0S-757N, 6K0S-504F, 7K0S100578, 6K0S-482K, 6K0S-485K, 6K0S-981P, 6K0S-007Q, 6K0S-805K, 6K0S-777R, 7K0S102982, 7K0S100940, 5K0S-Z666, 6K0S-484J, 6K0S-325L, 6K0S-486J, 6K0S-010M, 7K0S100714, 6K0S-006M, 6K0S-060N, 6K0S-432N, 6K0S-787R, 6K0S-952Q, 7K0S100579, 7K0S107999, 6K0S-017R, 7K0S102656, 6K0S-750N, 5K0S-882D, 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8K0S131440, 8K0S131441, 8K0S131442, 8K0S131443, 8K0S131444, 8K0S131446, 8K0S131447, 6K0S-668L, 6K0S-721R, 6K0S-775R, 6K0S-779R, 6K0S-782R, 6K0S-957Q, 7K0S102597, 7K0S102600, 7K0S102660, 7K0S102663, 7K0S108312, 7K0S108484, 5K0S-312C, 5K0S-Y004, 6K0S-020M, 6K0S-333H, 6K0S-481G, 6K0S-493J, 6K0S-772R, 7K0S100719, 7K0S102602, 7K0S108327, 6K0S-335H, 6K0S-485J, 6K0S-489J, 6K0S-517F, 6K0S-716R, 6K0S-771R, 6K0S-809K, 6K0S-849G, 7K0S102603, 7K0S102662, 0K0S151413, 5K0S-308C, 5K0S-T139, 5K0S-Y001, 6K0S-492J, 6K0S-745N, 7K0S100720, 9K0S134408, 9K0S134500, 1K0S167702, 1K0S167703, 1K0S167704, 1K0S167705, 1K0S167706, 1K0S167707, 1K0S167708, 1K0S167709, 1K0S167710, 1K0S167711, 1K0S167712, 1K0S167713, 1K0S167714, 1K0S167715, 1K0S167716, 1K0S167717, 1K0S167718, 1K0S167719, 1K0S167720, 1K0S167721, 1K0S169224, 1K0S169226, 1K0S169227, 1K0S169228, 1K0S169229, 1K0S169231, 1K0S169232, 1K0S169235, 1K0S169238, 1K0S169239, 1K0S169240, 1K0S169241, 1K0S169242, 1K0S169243, 1K0S169244, 1K0S169225, 1K0S169230, 1K0S169233, 1K0S169234, 1K0S169236, 1K0S169237, 1K0S170300, 1K0S170301, 1K0S170302, 1K0S170303, 1K0S170304, 1K0S170305, 1K0S170306, 1K0S170309, 1K0S170310, 1K0S170311, 2K0S174112, 2K0S174113, 2K0S174114, 2K0S174115, 2K0S174116, 2K0S174117, 2K0S174118, 2K0S174119, 2K0S174120, 2K0S174121, 2K0S174122, 2K0S174123, 2K0S174124, 2K0S174125, 2K0S174126, 2K0S174127, 2K0S174128, 2K0S174129, 2K0S174131, 2K0S174132, 2K0S174133, 2K0S174134, 2K0S174136, 2K0S174137, 2K0S174138, 2K0S174139, 2K0S174140, 2K0S174141, 2K0S174142, 2K0S174144, 2K0S174145, 2K0S174146, 2K0S174147, 2K0S174148, 2K0S174149, 2K0S174229, 2K0S174230, 2K0S174232, 2K0S174234, 2K0S174235, 2K0S174236, 2K0S174237, 2K0S174238, 2K0S174239, 2K0S174240, 2K0S174241, 2K0S174244, 2K0S174245, 2K0S174246, 2K0S174130, 2K0S174135, 2K0S174228, 2K0S174231, 2K0S174233, 2K0S174242, 2K0S174243, 2K0S175602, 2K0S175603, 2K0S175605, 2K0S175606, 2K0S175607, 2K0S175608, 2K0S175609, 2K0S175610, 2K0S175611, 2K0S175612, 2K0S175613, 2K0S175614, 2K0S175615, 2K0S175616, 2K0S177609, 2K0S177610, 2K0S177611, 2K0S177612, 2K0S177613, 2K0S177614, 2K0S177615, 2K0S177616, 2K0S177617, 2K0S177618, 2K0S177619, 2K0S177620, 2K0S177621, 2K0S177622, 2K0S177623, 2K0S177624, 2K0S177625, 2K0S177626, 2K0S177627, 2K0S177628, 2K0S181311, 2K0S181312, 2K0S181313, 2K0S181314, 2K0S181317, 2K0S181318, 2K0S181320, 2K0S181321, 2K0S181322, 2K0S181323, 2K0S181324, 2K0S181325, 2K0S181326, 2K0S181328, 2K0S181329, 2K0S181331, 2K0S181332, 2K0S181339, 2K0S181344, 2K0S181346, 2K0S181315, 2K0S181316, 2K0S181319, 2K0S181327, 2K0S181330, 2K0S181338, 2K0S181340, 2K0S181343, 2K0S181345, 2K0S181347, 3K0S183305, 3K0S183306, 3K0S183307, 3K0S183308, 3K0S183309, 3K0S183310, 3K0S183311, 3K0S183312, 3K0S183313, 3K0S183314, 3K0S183315, 3K0S183316, 3K0S183317, 3K0S183318, 3K0S183319, 3K0S183320, 3K0S183321, 3K0S183322, 3K0S183323, 3K0S183324, 3K0S183906, 3K0S183907, 3K0S183908, 3K0S183909, 3K0S183910, 3K0S183911, 3K0S183912, 3K0S183913, 3K0S183914, 3K0S183915, 3K0S183916, 3K0S183917, 3K0S183918, 3K0S183919, 3K0S183920, 3K0S183971, 3K0S183972, 3K0S183973, 3K0S183974, 3K0S183975, 3K0S183976, 3K0S183977, 3K0S183978, 3K0S183979, 3K0S183980, 3K0S184849, 3K0S184850, 3K0S184851, 3K0S184852, 3K0S184853, 3K0S184854, 3K0S184855, 3K0S184856, 3K0S184857, 3K0S184858, 3K0S184859, 3K0S184860, 3K0S184861, 3K0S184862, 3K0S184863, 2K0S174143, 2K0S175604, 4K0S190837, 4K0S190838, 4K0S190842, 4K0S190843, 4K0S190829, 4K0S190830, 4K0S190831, 4K0S190832, 4K0S190833, 4K0S190834, 4K0S190835, 4K0S190836, 4K0S190839, 4K0S190840, 4K0S190841, 5K0S192866, 5K0S192867, 5K0S192868, 5K0S192869, 5K0S192907, 5K0S192985, 5K0S-Z665, 6K0S-483K, 6K0S-801K, 6K0S-813K, 7K0S100575, 6K0S-996P, 7K0S102605, 6K0S-469G, 4K0S-J232, 4K0S-J943, 5K0S-878D, 6K0S-502F, 6K0S-533F, 6K0S-466G, 6K0S-470G, 6K0S-473G, 6K0S-476G, 6K0S-482G, 6K0S-483G, 6K0S-485G, 6K0S-013Q, 5K0S-162D, 5K0S-165D, 5K0S-161D, 6K0S-480G, 6K0S-061N, 7K0S107754, 7K0S107923, 7K0S110433, 5K0S-X988, 6K0S-006Q, 6K0S-008Q, 6K0S-008R, 6K0S-009Q, 6K0S-011Q, 6K0S-012Q, 6K0S-027Q, 6K0S-030Q, 6K0S-031Q, 6K0S-954Q, 7K0S108015, 7K0S108255, 7K0S109401, 7K0S109902, 7K0S110123, 7K0S110121, 5K0S-X981, 6K0S-194E, 7K0S105992, 4K0S-S714, 7K0S107994, 4K0S-L723, 4K0S-S703, 4K0S-S719, 4K0S-J944, 4K0S-J947, 7K0S103049, 7K0S102661, 6K0S-747N, 6K0S-749N, 6K0S-755N, 6K0S-758N, 7K0S104960, 7K0S105023, 7K0S105076, 7K0S105077, 7K0S105080, 7K0S100617, 7K0S102659, 7K0S102984, 7K0S103051, 7K0S106374.

Distribution pattern

Domestic: Nationwide Distribution. International: Canada.

device · product 5 of 8

RTL190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A

Z-2344-2024
Recall number
Z-2344-2024
Initiated
June 03, 2024
Classification
Class II
Status
Ongoing
Quantity
17 Units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Model Number: RTL190395 (Rental Units); UDI/DI: 00840861100958; Serial Numbers: 4K0S-R138, 5K0S-Z652, 5K0S-462B, 5K0S-Z669, 6K0S-505F, 6K0S-513F, 6K0S-850G, 6K0S-480J, 6K0S-467K, 6K0S-995P, 7K0S103784, 6K0S-009M, 7K0S110463, 7K0S110427, 7K0S110771, 6K0S-725R, 6K0S-324L,

Distribution pattern

Domestic: Nationwide Distribution. International: Canada.

device · product 6 of 8

RTL190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model Number: F40015481 Rev A

Z-2345-2024
Recall number
Z-2345-2024
Initiated
June 03, 2024
Classification
Class II
Status
Ongoing
Quantity
1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Model Number: RTL190828 (Rental Units); UDI/DI: 00840861100941; Serial Number: 1K0S172181

Distribution pattern

Domestic: Nationwide Distribution. International: Canada.

device · product 7 of 8

RTL190904: 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev A

Z-2346-2024
Recall number
Z-2346-2024
Initiated
June 03, 2024
Classification
Class II
Status
Ongoing
Quantity
2 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Model Number: RTL190904 (Rental Units); UDI/DI: 00840861100965; Serial Numbers: 5K0S193320, 5K0S194164.

Distribution pattern

Domestic: Nationwide Distribution. International: Canada.

device · product 8 of 8

RTLR190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A

Z-2347-2024
Recall number
Z-2347-2024
Initiated
June 03, 2024
Classification
Class II
Status
Ongoing
Quantity
6 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Model Number: RTLR190395 (Refurbished Rental units); UDI/DI: 00840861100958; Serial Numbers: 6K0S-514F, 6K0S-472G, 6K0S-052M, 6K0S-058N, 5K0S-322B, 5K0S-U131.

Distribution pattern

Domestic: Nationwide Distribution. International: Canada.

Field note

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