FDA Device recall Z-1867-2024

2008T BlueStar Hemodialysis Machine, Model 191124 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 191124 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-1867-2024
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 191124 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: 191124, UDI/DI:… 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, 1T0S25592

code_info

Component: Model Number: F40015481 Rev A, UDI/DI: N/A, All Rev A lots. Finished Devices: Model Number: 191124, UDI/DI:…

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, 1T0S25592

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-1867-2024%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.