FDA recall Z-3017-2026

Fresenius Medical Care Renal Therapies Group, LLC · Class II · device

Product

Fresenius Medical Care, 2008T BlueStar Hemodialysis Machine, Model Numbers: 191126, 191130.

Reason for recall

Fresenius Medical Care Renal Therapies Group, LLC (FMCRTG) has received complaints regarding flow-, no water-, or temperature-related alarms with the 2008T¿ BlueStar Hemodialysis machines.

Distribution

US Nationwide distribution.

Key facts

Status: Ongoing
Initiation date: 2026-06-30
Report date: 2026-09-02
Voluntary/Mandated: Voluntary: Firm initiated
Location: Waltham, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3017-2026