Company: Fresenius Medical Care Holdings, Inc.
Date of Enforcement Report: 4/29/2020
Class II

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

Recall Number: Z-1748-2020

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/MANUFACTURER

Fresenius Medical Care Holdings, Inc. on 3/12/2020. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

101,463

DISTRIBUTION

US Nationwide and International