Z-1869-2024Class II

2008T BlueStar Hemodialysis Machine, Model 191128 with Component: Blood Pump Rotor, Model Number: F40015481...

Name: Z-1869-2024 2008T BlueStar Hemodialysis Machine, Model 191128 with Component: Blood Pump Rotor, Model Number: F40015481...
Creator: Fresenius Medical Care Holdings, Inc.
Published: 2024-04-17
License: https://open.fda.gov/license/

Fresenius Medical Care Renal Therapies Group, LLC / initiated 2024-04-17 / Open, Classified / root cause: design

FDA source

Fresenius Medical Care Holdings, Inc. began a recall of 2008T BlueStar Hemodialysis Machine, Model 191128 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A on 2024-04-17. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1869-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-04-17
Posted: 2024-05-17
Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC
Product: 2008T BlueStar Hemodialysis Machine, Model 191128 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.
Product code: KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
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.
Root cause tag: design
FDA root cause: Device Design
Action: On April 17, 2024 IMPORTANT MEDICAL DEVICE CORRECTION letters were sent to customers. Customer actions: As per the 2008T Operators Manual P/N 490122 Rev AA: Blood Pump Rotors should be inspected for proper operation, as stated in Chapter 2: Daily preparation for treatment. If you experience a dislodged guide post sleeve, bent or loose tubing guide posts, or roller cannot move freely on your current F40015481 Rev A blood pump rotor, please contact FMCRTG Technical Support Services at 800-405-1321 for a replacement Blood Pump Rotor (Part Number, F40015481, Rev C) . Have Rotor Lot Number available when requesting a replacement. Please provide this letter to your Biomedical Technician or trained personnel. Report any complaints or adverse events to [email protected] or FDA MedWatch at https://www.fda.gov/safety/medical-product-safety-information/medwatch-forms-fda-safety-reporting. Provide this Customer Notice to all those who need to be aware within your organization. Complete and return the attached reply form. Biomedical Technician/ actions: A Field Service Bulletin will be posted to fmcna.com website regarding Preventative Maintenance activities for Blood Pump Rotor Tubing Guide Inspection of the need to inspect the blood pump tubing guides during the 6-month Preventive Maintenance on all 2008 Series Hemodialysis Machines. URL: https://fmcna.com/support/product-support-documents/field-service-bulletins/ For any clinical or medical questions, please contact the Global Medical Information and Education Office at 1-855-616-2309.
Quantity in commerce: 334 units
Distribution: US Nationwide distribution.
Product codes and lots: Component: Model Number: F40015481 Rev A, UDI/DI: N/A, All Rev A lots. Finished Devices: Model Number: 191128, UDI/DI: 00840861102105; Serial Numbers: 3T0S274210, 1T0S260183, 1T0S260455, 1T0S260456, 1T0S260485, 1T0S260273, 1T0S260283, 1T0S260490, 1T0S260158, 1T0S260182, 1T0S260266, 3T0S269011, 3T0S273223, 3T0S274216, 3T0S274225, 3T0S274678, 3T0S274680, 1T0S260281, 2T0S268008, 2T0S268016, 2T0S264775, 2T0S268009, 2T0S268013, 2T0S268014, 2T0S268015, 3T0S269021, 3T0S269026, 3T0S274215, 3T0S274222, 3T0S274231, 3T0S274234, 1T0S260154, 1T0S260481, 1T0S260543, 1T0S260550, 1T0S260552, 3T0S274213, 3T0S274230, 1T0S260242, 1T0S260250, 1T0S260510, 1T0S260514, 2T0S267901, 2T0S267905, 2T0S267906, 2T0S267911, 1T0S260541, 1T0S260546, 2T0S264780, 3T0S274233, 3T0S274685, 3T0S274691, 3T0S274697, 1T0S260159, 1T0S260164, 1T0S260172, 1T0S260212, 1T0S260216, 1T0S260221, 1T0S260269, 1T0S260270, 1T0S260276, 1T0S260292, 1T0S260295, 1T0S260528, 3T0S273221, 3T0S274217, 3T0S274218, 3T0S274219, 3T0S274220, 3T0S274223, 3T0S274226, 3T0S274227, 3T0S274228, 3T0S274232, 3T0S274682, 3T0S274684, 3T0S274690, 3T0S274692, 3T0S274693, 3T0S274698, 1T0S260150, 1T0S260174, 1T0S260192, 1T0S260554, 1T0S260534, 3T0S274214, 3T0S274688, 1T0S260286, 2T0S264786, 3T0S274679, 3T0S274681, 3T0S274683, 3T0S274686, 3T0S274694, 3T0S274695, 3T0S274699, 3T0S274700, 1T0S260544, 1T0S260268, 1T0S260294, 3T0S269020, 3T0S269030, 3T0S269031, 1T0S260227, 2T0S267900, 2T0S267904, 1T0S260284, 1T0S260457, 1T0S260548, 3T0S269013, 3T0S269015, 3T0S269028, 3T0S271557, 3T0S271562, 3T0S271563, 3T0S271570, 3T0S271571, 3T0S271573, 3T0S271574, 3T0S271575, 3T0S271576, 3T0S269033, 3T0S269035, 3T0S271561, 3T0S271566, 3T0S271568, 3T0S273244, 1T0S260493, 1T0S260501, 1T0S260506, 1T0S260515, 1T0S260526, 1T0S260279, 1T0S260155, 1T0S260156, 1T0S260166, 1T0S260167, 1T0S260185, 1T0S260188, 1T0S260200, 3T0S269014, 3T0S269016, 3T0S269022, 2T0S264805, 2T0S264776, 2T0S264778, 2T0S264794, 2T0S264818, 2T0S264822, 2T0S264787, 2T0S264792, 3T0S269017, 3T0S269018, 3T0S269019, 3T0S271558, 3T0S271560, 3T0S271564, 3T0S271565, 3T0S271572, 1T0S256406, 2T0S267910, 3T0S273219, 3T0S273232, 3T0S274221, 1T0S260151, 1T0S260178, 1T0S260152, 1T0S260278, 1T0S260288, 1T0S260488, 1T0S260533, 1T0S260249, 1T0S260259, 1T0S260262, 1T0S260198, 1T0S260291, 2T0S268012, 1T0S260173, 3T0S274211, 3T0S274224, 2T0S268011, 3T0S273220, 3T0S273222, 3T0S273224, 3T0S273225, 3T0S273226, 3T0S273227, 3T0S273228, 3T0S273229, 3T0S273230, 3T0S273233, 3T0S273234, 3T0S273235, 3T0S273236, 3T0S273237, 3T0S273238, 3T0S273239, 3T0S273240, 3T0S273241, 3T0S273242, 3T0S273243, 1T0S260267, 1T0S260275, 3T0S269012, 3T0S269023, 3T0S269024, 3T0S269025, 3T0S269027, 3T0S269029, 3T0S269032, 3T0S269034, 1T0S260204, 1T0S260460, 1T0S260482, 1T0S260513, 1T0S260516, 1T0S260527, 1T0S260540, 1T0S260545, 2T0S267903, 2T0S264781, 3T0S271559, 3T0S271567, 3T0S271569, 1T0S260290, 1T0S260175, 1T0S260282, 1T0S260508, 1T0S260566, 1T0S260285, 2T0S264783, 2T0S264814, 1T0S260157, 1T0S260161, 1T0S260162, 1T0S260163, 1T0S260165, 1T0S260169, 1T0S260176, 1T0S260177, 1T0S260179, 1T0S260187, 1T0S260189, 1T0S260191, 1T0S260193, 1T0S260195, 1T0S260196, 1T0S260197, 1T0S260199, 1T0S260201, 1T0S260202, 1T0S260203, 1T0S260207, 1T0S260208, 1T0S260209, 1T0S260210, 1T0S260211, 1T0S260213, 1T0S260214, 1T0S260215, 1T0S260217, 1T0S260218, 1T0S260219, 1T0S260220, 1T0S260222, 1T0S260223, 1T0S260224, 1T0S260225, 1T0S260228, 1T0S260229, 1T0S260230, 1T0S260231, 1T0S260232, 1T0S260233, 1T0S260235, 1T0S260236, 1T0S260237, 1T0S260239, 1T0S260243, 1T0S260245, 1T0S260247, 1T0S260251, 1T0S260253, 1T0S260255, 1T0S260256, 1T0S260257, 1T0S260258, 1T0S260260, 1T0S260272, 1T0S260453, 1T0S260458, 1T0S260459, 1T0S260483, 1T0S260500, 1T0S260502, 1T0S260507, 1T0S260519, 1T0S260523, 1T0S260531, 1T0S260542, 1T0S260549, 1T0S260553, 1T0S260565, 2T0S264774, 2T0S264777, 2T0S264779, 2T0S264782, 2T0S264784, 2T0S264788, 2T0S264791, 2T0S264793, 2T0S264796, 2T0S264797, 2T0S264800, 2T0S264801, 2T0S264803, 2T0S264804, 2T0S264807, 2T0S264811, 2T0S264819, 2T0S264821, 2T0S268010, 1T0S260194, 1T0S260238, 1T0S260293, 1T0S260461, 2T0S264802, 3T0S274212, 2T0S267899, 2T0S267902, 2T0S267907, 2T0S267908, 2T0S267909.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1869-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1866-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-29	2024-05-17
Z-1867-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-29	2024-05-17
Z-1868-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-29	2024-05-17
Z-1869-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-29	2024-05-17
Z-1870-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-29	2024-05-17

Product code KDI

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)