Recall archive / FDA device enforcement
AQUABILITI AQUASTAT 0.9% Sodium Chloride Injection syringe, USP, 5mL in 12mL, REF 2T0805; and 3mL in 12mL, REF 2T0807... — FDA record Z-1174-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Dec 28, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Classification
- Class II
- Recalling firm
- MRP, LLC dba Aquabiliti
- Quantity
- 3,080,000 syringes
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1174-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | REF 2T0805 - Lot 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; UDI-DI 10859809005013. REF 2T0807 - 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; KH05026, exp. 10/26/2024; and KH05071, exp. 12/19/2024; UDI-DI 10859809005037. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Nationwide distribution in the states CO, FL, NC, NY, OH, PA, TN, TX, and VA.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Feb 28, 2024
- Recall initiation date
- Dec 28, 2023
- Center classification date
- Feb 22, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.