Recall Z-1748-2020— Fresenius Medical Care Holdings, Inc.

Name: FDA recall Z-1748-2020
Creator: U.S. Food and Drug Administration
Published: 2020-03-12

Class II · Ongoing

Class II FDA medical device recall by Fresenius Medical Care Holdings, Inc., initiated 2020-03-12. It names one FDA 510(k) clearance: K173972. Product: Fresenius 2008T Hemodialysis Machine: Part Number Description 190573 2008T HEMODIAL YSIS SYS. OLC/DIASAFE PLUS; 190713 2008T HEMODIAL YSIS SYS., with CDX; 190766 2008T HEMODIAL YSIS SYSTEM W/BIBAG; 190858 2008T HEMODIAL YSIS SYSTEM WITHOUT CDX; 190895 2008T GEN 2 BIBAG WITHOUT CDX; 190908 2008T HD System With CDX, CAN. Reason: A "Remove USB Device 2" false alarm may be displayed when no USB device or a non-powered USB device is connected to the USB port on the rear of the machine.

Recalling firm: Fresenius Medical Care Holdings, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2020-03-12
Firm location: Waltham, MA, United States

510(k) clearances named in this recall

1 on FDA's record

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

Fresenius 2008T Hemodialysis Machine: Part Number Description 190573 2008T HEMODIAL YSIS SYS. OLC/DIASAFE PLUS; 190713 2008T HEMODIAL YSIS SYS., with CDX; 190766 2008T HEMODIAL YSIS SYSTEM W/BIBAG; 190858 2008T HEMODIAL YSIS SYSTEM WITHOUT CDX; 190895 2008T GEN 2 BIBAG WITHOUT CDX; 190908 2008T HD System With CDX, CAN

Reason for recall

A "Remove USB Device 2" false alarm may be displayed when no USB device or a non-powered USB device is connected to the USB port on the rear of the machine

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