Recall Z-3092-2026— Fresenius Medical Care Renal Therapies Group, LLC
Class II · Ongoing
Class II FDA medical device recall by Fresenius Medical Care Renal Therapies Group, LLC, initiated 2026-07-14. It names 2 FDA 510(k) clearances: K212620, K192017. 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: Complaints of blue-green discoloration in product.
- Recalling firm
- Fresenius Medical Care Renal Therapies Group, LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-07-14
- Firm location
- Waltham, MA, United States
510(k) clearances named in this recall
2 on FDA's record- K212620 — Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate
- K192017 — Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate
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
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.