Class II

Medical Device Recall: 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 syrin

MRP, LLC dba Aquabiliti · December 28, 2023

Reason for Recall

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

Product Description

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.

Distribution

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

States Affected

NATIONWIDE

Quantity Affected

3,080,000 syringes

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1174-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.