FDA Device recall Z-1869-2024

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

FDA Device
Class II
ongoing
Published 2024-05-29

On 2024-05-29 the FDA classified a Class II recall of 2008T BlueStar Hemodialysis Machine, Model 191128 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A by Fresenius Medical Care Holdings, citing 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.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1869-2024
Classification	Class II
Status	ongoing
Initiated	2024-04-17
Published	2024-05-29
Last updated	2026-09-13 11:57 UTC
Company	Fresenius Medical Care Holdings
Distribution	US

Product

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

Identifiers

code_info	Component: Model Number: F40015481 Rev A, UDI/DI: N/A, All Rev A lots. Finished Devices: Model Number: 191128, UDI/DI:… 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, 3T0S27422

code_info

Component: Model Number: F40015481 Rev A, UDI/DI: N/A, All Rev A lots. Finished Devices: Model Number: 191128, UDI/DI:…

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, 3T0S27422

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1869-2024%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.