FDA-Device2024-02-28Class II
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.
MRP, LLC dba Aquabiliti
Hazard
The saline flush syringes may fail to meet USP criteria for stated sodium chloride content after 12 months.
Sold states
US Nationwide distribution in the states CO, FL, NC, NY, OH, PA, TN, TX, and VA.
Affected count
3,080,000 syringes
Manufactured in
5209 Linbar Dr Ste 640, N/A, Nashville, TN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1174-2024Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief