Recall Z-1174-2024— MRP, LLC dba Aquabiliti

Name: FDA recall Z-1174-2024
Creator: U.S. Food and Drug Administration
Published: 2023-12-28

Class II · Ongoing

Class II FDA medical device recall by MRP, LLC dba Aquabiliti, initiated 2023-12-28. It names one FDA 510(k) clearance: K113555. 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: The saline flush syringes may fail to meet USP criteria for stated sodium chloride content after 12 months..

Recalling firm: MRP, LLC dba Aquabiliti
Classification: Class II
Status: Ongoing
Initiated: 2023-12-28
Firm location: Nashville, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K113555 — AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGEAm USA·cleared 2012-01-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.