Recall Z-1868-2024— Fresenius Medical Care Holdings, Inc.

Name: FDA recall Z-1868-2024
Creator: U.S. Food and Drug Administration
Published: 2024-04-17

Class II · Ongoing

Class II FDA medical device recall by Fresenius Medical Care Holdings, Inc., initiated 2024-04-17. It names 3 FDA 510(k) clearances: K231125, K222952, K173972. Product: 2008T BlueStar Hemodialysis Machine, Model 191126 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..

Recalling firm: Fresenius Medical Care Holdings, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2024-04-17
Firm location: Waltham, MA, United States

510(k) clearances named in this recall

3 on FDA's record

K231125 — 2008T BlueStar Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC·cleared 2023-12-06
K222952 — 2008T BlueStar Hemodailysis MachineFresenius Medical Care Renal Therapies Group, LLC·cleared 2022-10-27
K173972 — 2008T BlueStar Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC·cleared 2018-05-10

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

2008T BlueStar Hemodialysis Machine, Model 191126 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.