FDA Device recall Z-1870-2024

2008T BlueStar Hemodialysis Machine, Model 191130 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 191130 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-1870-2024
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 191130 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: 191130, UDI/DI:… Component: Model Number: F40015481 Rev A, UDI/DI: N/A, All Rev A lots. Finished Devices: Model Number: 191130, UDI/DI: 00840861102112; Serial Numbers: 2T0S265095, 2T0S265131, 2T0S266383, 2T0S266406, 2T0S266459, 0T0S251328, 0T0S251333, 0T0S251334, 0T0S251335, 0T0S251337, 0T0S251338, 0T0S251343, 0T0S251345, 0T0S251347, 0T0S251348, 0T0S251349, 0T0S251354, 0T0S251363, 0T0S251365, 0T0S251368, 0T0S251370, 0T0S251375, 0T0S251385, 0T0S251401, 0T0S251413, 0T0S251419, 0T0S254338, 0T0S254385, 0T0S252442, 0T0S252451, 0T0S252453, 2T0S268393, 3T0S273665, 0T0S254884, 0T0S254888, 0T0S254893, 4T0S277762, 4T0S277765, 4T0S277775, 4T0S277785, 4T0S277787, 4T0S277791, 4T0S277793, 4T0S277795, 4T0S277800, 4T0S277801, 4T0S277802, 4T0S277806, 4T0S277807, 4T0S277808, 4T0S277812, 4T0S277817, 4T0S277818, 4T0S277821, 4T0S277822, 4T0S277831, 4T0S277860, 4T0S277869, 3T0S270989, 3T0S270996, 3T0S271096, 3T0S271365, 3T0S271366, 3T0S271368, 3T0S271370, 3T0S271372, 3T0S271374, 3T0S271375, 3T0S271386, 3T0S271388, 3T0S27139

code_info

Component: Model Number: F40015481 Rev A, UDI/DI: N/A, All Rev A lots. Finished Devices: Model Number: 191130, UDI/DI:…

Component: Model Number: F40015481 Rev A, UDI/DI: N/A, All Rev A lots. Finished Devices: Model Number: 191130, UDI/DI: 00840861102112; Serial Numbers: 2T0S265095, 2T0S265131, 2T0S266383, 2T0S266406, 2T0S266459, 0T0S251328, 0T0S251333, 0T0S251334, 0T0S251335, 0T0S251337, 0T0S251338, 0T0S251343, 0T0S251345, 0T0S251347, 0T0S251348, 0T0S251349, 0T0S251354, 0T0S251363, 0T0S251365, 0T0S251368, 0T0S251370, 0T0S251375, 0T0S251385, 0T0S251401, 0T0S251413, 0T0S251419, 0T0S254338, 0T0S254385, 0T0S252442, 0T0S252451, 0T0S252453, 2T0S268393, 3T0S273665, 0T0S254884, 0T0S254888, 0T0S254893, 4T0S277762, 4T0S277765, 4T0S277775, 4T0S277785, 4T0S277787, 4T0S277791, 4T0S277793, 4T0S277795, 4T0S277800, 4T0S277801, 4T0S277802, 4T0S277806, 4T0S277807, 4T0S277808, 4T0S277812, 4T0S277817, 4T0S277818, 4T0S277821, 4T0S277822, 4T0S277831, 4T0S277860, 4T0S277869, 3T0S270989, 3T0S270996, 3T0S271096, 3T0S271365, 3T0S271366, 3T0S271368, 3T0S271370, 3T0S271372, 3T0S271374, 3T0S271375, 3T0S271386, 3T0S271388, 3T0S27139

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-1870-2024%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.