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

Class I - Dangerous

🏥 Medical Devices Recalled: June 3, 2024 Fresenius Medical Care Holdings Infusion Pumps Nationwide

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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, 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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.
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:

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

Product Codes/Lot Numbers:

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, 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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.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2343-2024

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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

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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.

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