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

Class I - Dangerous

🏥 Medical Devices Recalled: April 17, 2024 Fresenius Medical Care Holdings Infusion Pumps Nationwide

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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, 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0T0S251852, 0T0S252109, 0T0S252187, 0T0S252532, 0T0S252570, 0T0S252574, 0T0S252575, 1T0S255905, 2T0S264827, 2T0S264831, 2T0S264836, 2T0S264843, 2T0S264847, 2T0S264850, 2T0S264854, 2T0S264858, 2T0S264878, 2T0S264888, 0T0S251896, 0T0S252142, 0T0S252147, 0T0S252149, 0T0S251490, 1T0S255903, 3T0S269277,
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: Fresenius Medical Care Holdings, Inc.
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.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: ongoing

Product Information

Full Description:

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

Product Codes/Lot Numbers:

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, 3T0S272497, 3T0S272499, 3T0S272501, 3T0S272502, 3T0S272503, 3T0S272504, 3T0S272508, 1T0S255927, 1T0S255961, 1T0S255962, 1T0S255968, 1T0S255970, 1T0S255975, 1T0S255976, 1T0S255977, 1T0S255980, 1T0S255981, 1T0S255983, 1T0S255984, 1T0S255986, 1T0S255988, 1T0S255989, 1T0S255991, 1T0S255992, 1T0S255994, 1T0S255996, 1T0S256009, 3T0S270349, 3T0S270975, 3T0S270979, 3T0S270981, 3T0S270983, 3T0S274179, 3T0S274181, 3T0S274196, 3T0S274198, 3T0S274199, 3T0S274200, 3T0S274450, 3T0S274461, 3T0S274469, 3T0S274470, 3T0S274473, 3T0S274474, 3T0S274476, 3T0S274477, 3T0S274634, 3T0S274431, 3T0S274432, 3T0S274435, 3T0S274436, 3T0S274437, 3T0S274438, 3T0S274440, 3T0S274441, 3T0S274442, 3T0S274445, 3T0S274446, 3T0S274452, 3T0S274459, 3T0S274464, 3T0S274466, 3T0S274472, 3T0S274624, 3T0S274625, 3T0S274628, 3T0S274629, 3T0S274630, 3T0S274632, 3T0S274641, 3T0S274653, 3T0S274655, 3T0S274658, 3T0S274662, 3T0S274664, 3T0S274666, 3T0S274667, 3T0S274668, 3T0S274669, 3T0S274671, 3T0S274674, 3T0S274676, 1T0S256195, 1T0S256214, 1T0S256242, 1T0S256243, 1T0S256246, 1T0S256248, 1T0S256253, 1T0S256258, 1T0S256260, 1T0S256263, 1T0S256280, 1T0S256290, 0T0S251796, 0T0S251806, 0T0S251855, 0T0S251922, 0T0S252098, 0T0S252114, 0T0S252115, 3T0S270329, 3T0S270331, 3T0S270340, 3T0S270343, 3T0S270351, 3T0S270362, 3T0S270363, 0T0S251526, 0T0S251577, 1T0S256198, 1T0S256226, 1T0S256259, 1T0S256265, 1T0S255898, 1T0S255926, 1T0S255909, 1T0S255920, 1T0S255935, 1T0S255978, 1T0S255982, 3T0S270325, 3T0S270328, 3T0S270339, 3T0S270357, 3T0S270963, 3T0S270966, 3T0S270976, 3T0S270978, 3T0S270984, 3T0S270986, 3T0S270326, 3T0S270334, 3T0S270337, 3T0S270347, 0T0S251840, 0T0S251850, 0T0S251908, 0T0S252089, 0T0S252118, 0T0S252127, 0T0S252165, 0T0S252171, 0T0S252173, 0T0S252514, 0T0S252521, 0T0S252553, 0T0S252557, 1T0S255932, 2T0S264855, 2T0S264882, 2T0S264883, 2T0S264886, 2T0S264890, 3T0S270341, 3T0S270342, 3T0S270352, 3T0S270354, 3T0S270359, 3T0S270360, 3T0S270361, 0T0S251300, 0T0S251541, 0T0S252516, 0T0S252522, 0T0S252526, 0T0S252528, 0T0S252533, 0T0S252535, 0T0S252539, 0T0S252547, 0T0S252566, 0T0S252567, 0T0S252571, 0T0S252573, 0T0S252580, 0T0S252863, 2T0S267873, 2T0S267874, 2T0S267875, 2T0S267876, 2T0S267877, 2T0S267878, 2T0S267879, 2T0S267880, 2T0S267881, 2T0S267882, 2T0S267883, 2T0S267884, 2T0S267999, 2T0S268000, 2T0S268001, 2T0S268002, 2T0S268003, 2T0S268004, 2T0S268005, 2T0S268006, 2T0S268007, 3T0S270971, 3T0S270982, 0T0S252548, 1T0S255891, 3T0S270358, 3T0S274188, 3T0S270338, 0T0S252830, 0T0S252839, 0T0S252848, 0T0S252849, 0T0S252851, 0T0S252861, 0T0S252866, 0T0S251309, 0T0S252122, 1T0S256189, 1T0S256247, 1T0S256283, 0T0S252104, 2T0S264885, 0T0S251578, 0T0S251615, 1T0S256234, 1T0S256241, 1T0S256269, 3T0S270333, 3T0S270977, 3T0S272488, 3T0S272506, 0T0S251539, 0T0S251566, 0T0S251570, 0T0S251588, 0T0S251591, 1T0S255997, 0T0S251512, 0T0S251567, 1T0S255949, 1T0S256011, 1T0S256013, 1T0S256014, 1T0S256230, 1T0S256236, 1T0S256238, 1T0S256264, 1T0S256267, 1T0S256291, 0T0S251832, 0T0S251833, 0T0S251909, 0T0S251498, 0T0S251575, 1T0S255947, 1T0S255953, 1T0S255956, 1T0S255957, 1T0S255959, 1T0S256218, 1T0S256251, 0T0S251851, 0T0S251858, 0T0S251859, 0T0S251863, 0T0S251865, 0T0S251870, 0T0S251871, 0T0S251877, 0T0S251882, 0T0S251894, 0T0S251904, 0T0S251910, 1T0S256199, 0T0S252141, 0T0S252178, 0T0S252189, 0T0S252524, 0T0S252536, 1T0S255950, 1T0S256200, 1T0S256204, 2T0S264823, 0T0S252796, 0T0S252855, 1T0S255941, 1T0S255952, 0T0S251290, 0T0S251316, 0T0S251496, 0T0S251518, 1T0S255951, 1T0S255954, 1T0S255955, 1T0S255958, 1T0S255960, 1T0S255965, 1T0S255966, 1T0S255967, 1T0S255969, 1T0S255971, 1T0S255972, 1T0S255973, 1T0S255979, 1T0S255889, 1T0S255890, 1T0S255963, 3T0S274455, 3T0S274456, 3T0S274675, 1T0S256206, 1T0S256216, 1T0S256223, 1T0S255964, 0T0S252108, 1T0S255899, 1T0S256208, 0T0S252153, 0T0S252820, 0T0S252832, 0T0S252846, 0T0S252854, 0T0S252864, 0T0S252111, 0T0S252515, 0T0S252552, 0T0S251308, 0T0S251545, 0T0S252555, 0T0S251534, 1T0S255892, 1T0S256194, 1T0S256221, 1T0S256224, 1T0S256240, 0T0S251927, 0T0S252093, 0T0S252125, 0T0S252129, 0T0S252137, 0T0S252158, 0T0S252164, 0T0S252169, 1T0S256178, 1T0S256181, 1T0S256182, 1T0S256187, 1T0S256191, 1T0S256196, 1T0S256202, 1T0S256232, 1T0S256237, 1T0S256289, 0T0S252517, 0T0S252543, 1T0S256177, 1T0S256203, 1T0S256211, 1T0S256217, 1T0S256239, 1T0S256244, 1T0S256250, 1T0S256252, 1T0S256254, 1T0S256257, 1T0S256261, 1T0S256268, 1T0S256277, 1T0S256288, 0T0S251842, 0T0S251853, 0T0S251868, 0T0S251869, 0T0S251891, 2T0S264824, 2T0S264844, 3T0S270327, 3T0S270330, 3T0S270332, 3T0S270335, 3T0S270348, 3T0S270353, 0T0S251913, 0T0S252101, 3T0S272505, 3T0S270336, 3T0S270344, 3T0S270350, 0T0S250989, 2T0S264838, 2T0S264879, 3T0S270355, 3T0S270364, 3T0S274439, 1T0S256201, 1T0S256227, 1T0S256287, 0T0S252826, 0T0S252836, 1T0S255895, 1T0S255906, 1T0S255907, 1T0S255912, 1T0S255916, 1T0S255917, 1T0S255919, 1T0S255922, 0T0S252834, 0T0S252837, 1T0S255910, 0T0S251854, 0T0S251827, 0T0S251860, 0T0S251862, 0T0S251895, 1T0S255911, 1T0S255918, 1T0S255995, 1T0S256186, 1T0S256284, 2T0S264841, 0T0S251890, 0T0S252140, 0T0S251306, 0T0S251507, 0T0S251531, 0T0S251561, 0T0S251601, 0T0S251773, 0T0S251775, 0T0S251776, 0T0S251777, 0T0S251780, 0T0S251781, 0T0S251782, 0T0S251785, 0T0S251788, 0T0S251799, 0T0S251800, 0T0S251801, 0T0S251803, 0T0S251807, 0T0S251812, 0T0S251815, 0T0S251816, 0T0S251819, 0T0S251822, 0T0S251823, 0T0S251824, 0T0S251829, 0T0S251830, 0T0S251831, 0T0S251835, 0T0S251838, 0T0S251841, 0T0S251900, 0T0S251937, 0T0S251938, 0T0S252092, 0T0S252117, 0T0S252157, 0T0S252160, 0T0S252550, 0T0S252803, 0T0S252817, 0T0S252823, 1T0S255893, 1T0S256209, 1T0S256210, 1T0S256279, 1T0S256409, 2T0S264825, 2T0S264835, 2T0S264840, 2T0S264846, 2T0S264851, 2T0S264877, 2T0S264880, 2T0S264884, 2T0S264887, 3T0S269257, 3T0S269258, 3T0S269259, 3T0S269260, 3T0S269261, 3T0S269262, 3T0S269263, 3T0S269264, 3T0S269265, 3T0S269266, 3T0S269267, 3T0S269268, 3T0S269269, 3T0S269270, 3T0S269271, 3T0S269272, 3T0S269273, 3T0S269274, 3T0S269275, 3T0S269276, 3T0S269278, 3T0S269279, 3T0S269280, 3T0S269281, 3T0S270964, 3T0S270967, 3T0S270969, 3T0S270973, 3T0S270985, 3T0S270987, 3T0S272484, 3T0S272496, 3T0S272509, 3T0S274206, 0T0S251795, 0T0S251848, 0T0S251857, 0T0S251861, 0T0S252576, 1T0S255894, 1T0S255897, 2T0S264833, 2T0S264853, 2T0S264881, 3T0S270345, 3T0S270346, 3T0S270356, 3T0S270965, 3T0S272485, 3T0S272486, 3T0S272487, 3T0S272489, 3T0S272491, 3T0S272494, 3T0S272495, 3T0S272498, 3T0S274433, 3T0S274434, 3T0S274443, 3T0S274444, 3T0S274449, 3T0S274451, 3T0S274453, 3T0S274454, 3T0S274457, 3T0S274458, 3T0S274460, 3T0S274462, 3T0S274463, 3T0S274465, 3T0S274467, 3T0S274468, 3T0S274471, 3T0S274475, 3T0S274478, 0T0S251524, 0T0S251532, 0T0S251537, 0T0S251783, 1T0S256285, 0T0S251188, 0T0S251298, 0T0S251302, 0T0S251488, 0T0S251489, 0T0S251492, 0T0S251494, 0T0S251495, 0T0S251497, 0T0S251499, 0T0S251502, 0T0S251504, 0T0S251505, 0T0S251506, 0T0S251508, 0T0S251509, 0T0S251513, 0T0S251515, 0T0S251516, 1T0S255931, 1T0S255934, 1T0S255985, 0T0S252518, 0T0S252569, 1T0S255900, 1T0S255901, 2T0S264830, 2T0S264842, 2T0S264857, 0T0S251852, 0T0S252109, 0T0S252187, 0T0S252532, 0T0S252570, 0T0S252574, 0T0S252575, 1T0S255905, 2T0S264827, 2T0S264831, 2T0S264836, 2T0S264843, 2T0S264847, 2T0S264850, 2T0S264854, 2T0S264858, 2T0S264878, 2T0S264888, 0T0S251896, 0T0S252142, 0T0S252147, 0T0S252149, 0T0S251490, 1T0S255903, 3T0S269277,

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1867-2024

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Optiflux¿ High Flux E-beam Dialyzer Model Numbers: (1) 0500316E OPTIFLUX F160NRe 12/CS 1.5SA EBEAM, (2) 0500318E OPTIFLUX F180NRe 12/CS 1.7SA EBEAM, (3) 0500320E OPTIFLUX F200NRe 12/CS 1.9SA EBEAM, (4) 0500325E OPTIFLUX F250NRe 12/CS 2.5SA EBEAM

Fresenius Medical Care Holdings

Class I - Dangerous

To provide further information to the user to ensure proper use of the medical device. the caps had been changed from a threaded version to a press-on version whereby the user must press the caps firmly onto the dialyzer to securely affix the cap.

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0.9% Sodium Chloride Injection, USP, Flexible Plastic Container, Rx Only Fresenius Medical Care North America, Waltham, MA 02451, 1-800-323-5188, NDC 49230-300-10

Fresenius Medical Care Holdings

Class I - Dangerous

Lack of Assurance of Sterility

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5008X HDF Hemodialysis Blood Tubing Set, 24 units per case, with the following models: a. 5008X Standard HDF Bloodline, Model Number: 03-5100-7. b. 5008X Standard HDF Bloodline w/CLIC, Model Number: 03-5100-7C. c. 5008X Standard HDF Bloodline w/ Twister, Model Number: 03-5150-2.

Fresenius Medical Care Holdings

Class I - Dangerous

Potential of blood leak occurring between the lower port of the venous chamber and the tubing include: hemodiafiltration (HDF), hemodialysis (HD), hemofiltration (HF), and isolated ultrafiltration.

Apr 29, 2025 Other Medical Devices Nationwide View Details →