Recall archive / FDA device enforcement
190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A — FDA record Z-2343-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jun 3, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- 190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
- Reason
- 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 II
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Quantity
- 1,156 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2343-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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, 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8K0S131436, 8K0S131438, 8K0S131439, 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, ... |
The agency lot list is longer than this excerpt. Read the complete list at the official source.
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Domestic: Nationwide Distribution. International: Canada.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Jul 17, 2024
- Recall initiation date
- Jun 3, 2024
- Center classification date
- Jul 11, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.