FDA recall Z-3091-2026

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

Product

GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B; 0FD3251-3B; Dry Acid Concentrate for Bicarbonate Hemodialysis

Reason for recall

Complaints of blue-green discoloration in product

Distribution

Worldwide distribution - US Nationwide and the country of Mexico.

Key facts

Status
Ongoing
Initiation date
2026-07-14
Report date
2026-09-09
Voluntary/Mandated
Voluntary: Firm initiated
Location
Waltham, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3091-2026