FDA recall Z-3092-2026

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

Product

NaturaLyte, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-1251-1, 08-2251-0, 08-2301-3, 08-3251-9, 08-3301-2, 13-2201-5, 13-2251-0, 13-3251-9; Liquid 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-3092-2026