Recall Z-0035-2024— Fresenius Medical Care Holdings, Inc.

Name: FDA recall Z-0035-2024
Creator: U.S. Food and Drug Administration
Published: 2023-09-06

Class I · Ongoing

Class I FDA medical device recall by Fresenius Medical Care Holdings, Inc., initiated 2023-09-06. It names 3 FDA 510(k) clearances: K222952, K173972, K150708. Product: 2008T HD SYS. W/O CDX W/BIBAG BLUESTAR. Reason: Potential PCBA leaching from tubing of hemodialysis machines..

Recalling firm: Fresenius Medical Care Holdings, Inc.
Classification: Class I
Status: Ongoing
Initiated: 2023-09-06
Firm location: Waltham, MA, United States

510(k) clearances named in this recall

3 on FDA's record

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
K150708 — 2008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC·cleared 2015-12-10

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 HD SYS. W/O CDX W/BIBAG BLUESTAR

Reason for recall

Potential PCBA leaching from tubing of hemodialysis machines.

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