MRP, LLC dba Aquabiliti recalls AQUABILITI AQUASTAT 0.9% Sodium Chloride Injection syringe, USP, 5mL in 12mL, REF 2T0805; and 3mL in 12mL, REF 2T0807,…

Recall date

December 28, 2023

Source

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

Recall number

Z-1174-2024

FDA classification

Class II

Brand / firm

MRP, LLC dba Aquabiliti

Sold / distributed

US Nationwide distribution in the states CO, FL, NC, NY, OH, PA, TN, TX, and VA.

Why it was recalled

The saline flush syringes may fail to meet USP criteria for stated sodium chloride content after 12 months.

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

What was recalled

AQUABILITI AQUASTAT 0.9% Sodium Chloride Injection syringe, USP, 5mL in 12mL, REF 2T0805; and 3mL in 12mL, REF 2T0807, intermediate cartons containing 100 syringes, shipping cases containing 400 syringes, Rx, Sterile.