Reported Feb 28, 2024 · Ongoing

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

MRP, LLC dba Aquabiliti

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: MRP, LLC dba Aquabiliti · 5209 Linbar Dr Ste 640 · Nashville, TN · 37211-1026

Is this the product you have?

  • 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.
Lot codes and dates

23 of 23 products

Products covered by this recall
Model / numberBarcodesProduct as published
2T0805Lot numbers KH04910, exp. 1/11/2024
—KH04930, exp. 3/13/2024
—KH04954, exp. 5/22/2024
—KH04975, exp. 8/2/2024
—KH04990, exp. 9/6/2024
—KH05020, exp. 10/23/2024
—KH05022, exp. 10/24/2024
—KH05043, exp. 11/13/2024
—KH05066, exp. 12/13/2024
—KH05068, exp. 12/14/2024
—KH05070, exp. 12/18/2024
—KH05073, exp. 12/20/2024
—KH05134, exp. 6/25/2025
—KH05135, exp. 6/27/2025
—and KH05152, exp. 10/10/2025
2T080710859809005013UDI-DI 10859809005013. - Lot numbers KH04909, exp. 1/10/2024
—KH04944, exp. 4/24/2024
—KH04986, exp. 8/30/2024
—KH04988, exp. 9/5/2024
—KH05024, exp. 10/25/2024
Amount recalled
3,080,000 syringes

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Nov 5, 12:39 AM UTC

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