NaturaLyte¿ Liquid Acid Concentrate for Bicarbonate Dialysis recalled over labeling errors

Recall date

May 2, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Fresenius Medical Care Renal Therapies Group, LLC recalls NaturaLyte¿ Liquid Acid Concentrate for Bicarbonate Dialysis, 3.43 Liters, Part Number: 08-3231-1 Product Usage: This c…

Recall number

Z-2110-2018

FDA classification

Class II

Brand / firm

Fresenius Medical Care Renal Therapies Group, LLC

Sold / distributed

Worldwide Distribution - US Nationwide in the states: CA, IA, IL, IN, KS, MD, MI, MN, MS, NE, NJ, NV, OK, PA, SD, TX, and WI.

Why it was recalled

The bottles are mislabeled with an incorrect part number.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

NaturaLyte¿ Liquid Acid Concentrate for Bicarbonate Dialysis, 3.43 Liters, Part Number: 08-3231-1 Product Usage: This concentrate is formulated to be used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine. For every 45 volume parts of dialysate: 1 volume part of the NaturaLyte acid concentrate, 1.72 volume parts of FMCNA Sodium Bicarbonate Concentrate and 42.28 volume parts of Purified Water (AAMI quality) are used.