FDA recall Z-1174-2024

Product

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.

Reason for recall

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

Distribution

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

Key facts

Status

Ongoing

Initiation date

2023-12-28

Report date

2024-02-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Nashville, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1174-2024