Recall Z-0029-2024— Fresenius Medical Care Holdings, Inc.

Name: FDA recall Z-0029-2024
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 Hemodialysis System without CDX. 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 Hemodialysis System without CDX

Reason for recall

Potential PCBA leaching from tubing of hemodialysis machines.

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